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510(k) K925910

HEWLETT-PACKARD MODEL M1018A TCPO2/TOPCO2 MODULE by Hewlett-Packard Co. — Product Code KLK

K925910 is an FDA 510(k) premarket notification submitted by Hewlett-Packard Co. for the device "HEWLETT-PACKARD MODEL M1018A TCPO2/TOPCO2 MODULE". The FDA issued a decision of Substantially Equivalent on July 29, 1993. The device falls under product code KLK (Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia), a Class II device regulated under 21 CFR 868.2500. Hewlett-Packard Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 1993
Date Received
November 23, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
Device Class
Class II
Regulation Number
868.2500
Review Panel
AN
Submission Type

Other clearances by Hewlett-Packard Co.

  • K992543 — HEARTSTREAM XLT DEFIBRILLATOR/MONITOR, AC CHARGER, DC CHARGER, DATA CARD, SINGLE (May 18, 2000)
  • K993383 — HP VIRIDIA MULTI-MEASUREMENT SERVER/COMPACT PORTABLE PATIENT MONITOR MODELS M300 (February 3, 2000)
  • K992273 — HP VIRIDIA MULTI-MEASUREMENT SERVER/COMPACT PORTABLE PATIENT MONITOR M3000A/M304 (January 28, 2000)
  • K993587 — HP M2376A DEVICE LINK SYSTEM (January 20, 2000)
  • K993169 — MODIFICATION OF: PHYSIOLOGICAL SIGNAL TRANSMITTER AND RECEIVER, MODEL 3810A (December 20, 1999)
  • K992595 — HP VIRIDIA COMPONENT MONITORING SYSTEM, MODEL REV. K WITH EASI-ST SEGMENT MEASUR (December 8, 1999)
  • K992977 — HEWLETT PACKARD MULTIFUNCTION PEDIATRIC DEFIB FUNCTION, MODEL M3503A & M3504A (December 1, 1999)
  • K992674 — HP VIRIDIA CMS PATIENT MONITOR WITH EEG PARAMETER, MODEL M1027A (November 8, 1999)
  • K993516 — HP M2600A VIRIDIA TELEMETRY SYSTEM (November 8, 1999)
  • K993171 — HP VIRIDIA INFORMATION SYSTEM, MODELS M3150A/ M3151A/ M3153A/ M3154A (October 21, 1999)

Other clearances for product code KLK

  • K003943 — MICROGAS 7650 TRANSCUTANEOUS MONITOR (May 4, 2001)
  • K991644 — MICROGAS 7650 TRANSCUTANEOUS MONITOR (May 21, 1999)
  • K980287 — SIEMENS SC9000/SC9015 TCP02/C02 MODULE (August 12, 1998)
  • K924709 — SATCARE OXYGEN CONTROLLER/MONITOR W/ PULSE OXIMETE (January 17, 1996)
  • K924679 — OXYCARE(TM) OXYGEN CONTROLLER/MONITOR (February 21, 1995)
  • K893133 — HORIZON 2110/HORIZON 2210 264-XXX-XXX/261-XXX-XXX (July 14, 1989)
  • K870805 — MODEL 840 TRANSCUTAN. OXYGEN/CARBON DIOX. MONITOR (May 27, 1987)
  • K861861 — 515A NEO-TRAK NEONATAL MONITOR (July 10, 1986)
  • K860124 — HORIZON 2000 TRANSCUTANEOUS GAS MONITORING (May 9, 1986)
  • K860951 — KONTRON CUTANEOUS PO2 MONITOR 820 (April 9, 1986)

FDA data resources