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510(k) K924709

SATCARE OXYGEN CONTROLLER/MONITOR W/ PULSE OXIMETE by Air-Shields, Inc. — Product Code KLK

K924709 is an FDA 510(k) premarket notification submitted by Air-Shields, Inc. for the device "SATCARE OXYGEN CONTROLLER/MONITOR W/ PULSE OXIMETE". The FDA issued a decision of Substantially Equivalent on Jan 17, 1996. 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. Air-Shields, Inc. has 32 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jan 17, 1996
Date Received
Sep 18, 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
510(k) Exempt

Other clearances by Air-Shields, Inc.

  • K974248 — WATCHCHILD OBSTERICAL PATIENT DATA MANAGEMENT SYSTEM (Oct 7, 1998)
  • K972309 — JM-102 JAUNDICE METER (Sep 22, 1998)
  • K971256 — DUO-LITE PHOTOTHERAPY SYSTEM (Sep 24, 1997)
  • K960980 — ISOLETTE INFANT INCUBATOR (Jul 30, 1996)
  • K940951 — RW RESUCITAIRE INFANT RADIANT WARMER (May 3, 1995)
  • K940975 — C450/C400 INFANT INCUBATORS (Jun 23, 1994)
  • K941106 — MODEL TI500 ISOLETTE INFANT INCUBATOR (Jun 10, 1994)
  • K924170 — ISOLETTE INCUBATOR HUMIDITY METER (Feb 5, 1993)
  • K922150 — EXAMINATION LAMP (Jul 21, 1992)
  • K914864 — MODELS C500/C550 ISOLETE(R) INFANT INCUBATOR (Mar 13, 1992)

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 (Aug 12, 1998)
  • K924679 — OXYCARE(TM) OXYGEN CONTROLLER/MONITOR (Feb 21, 1995)
  • K925910 — HEWLETT-PACKARD MODEL M1018A TCPO2/TOPCO2 MODULE (Jul 29, 1993)
  • K893133 — HORIZON 2110/HORIZON 2210 264-XXX-XXX/261-XXX-XXX (Jul 14, 1989)
  • K870805 — MODEL 840 TRANSCUTAN. OXYGEN/CARBON DIOX. MONITOR (May 27, 1987)
  • K861861 — 515A NEO-TRAK NEONATAL MONITOR (Jul 10, 1986)
  • K860124 — HORIZON 2000 TRANSCUTANEOUS GAS MONITORING (May 9, 1986)
  • K860951 — KONTRON CUTANEOUS PO2 MONITOR 820 (Apr 9, 1986)

FDA data resources