Home / 510(k) Clearances / K791964

510(k) K791964

MODEL 15055A MAINFRAME by Hewlett-Packard Co. — Product Code DRR

K791964 is an FDA 510(k) premarket notification submitted by Hewlett-Packard Co. for the device "MODEL 15055A MAINFRAME". The FDA issued a decision of Substantially Equivalent on October 11, 1979. The device falls under product code DRR (Amplifier And Signal Conditioner, Biopotential), a Class II device regulated under 21 CFR 870.2050. Hewlett-Packard Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 11, 1979
Date Received
October 1, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Amplifier And Signal Conditioner, Biopotential
Device Class
Class II
Regulation Number
870.2050
Review Panel
CV
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 DRR

  • K022660 — BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117 (December 19, 2002)
  • K971570 — EPXPRESS SYSTEM (TIMBERWOLF REVISION) /000391 (December 29, 1997)
  • K925346 — EP AMP, MODEL #901 (April 30, 1993)
  • K914381 — HORIZON 9000/HIS OPTION AMPLIFIER (January 28, 1992)
  • K911935 — CARDIAC ELECTROPHYSICAL LEAD SELECTOR, MODIFIED (July 22, 1991)
  • K910307 — CARDIOLAB AMPLIFIER MODULE (CAM) (April 12, 1991)
  • K894735 — ASC-952 PHYSIOLOGICAL AMPLIFIER (September 18, 1989)
  • K894161 — ASC-950 ECG AMPLIFIER (August 3, 1989)
  • K874441 — BARD BIOPOTENTIAL AMPLIFIER (January 19, 1988)
  • K853652 — BERS-400A ELECTROPHYSIOLOGICAL AMPLIFIERS & INPUT (January 16, 1986)

FDA data resources