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510(k) K915658

SPECTRA ECG by Advanced Medical Products, Inc. — Product Code LOS

K915658 is an FDA 510(k) premarket notification submitted by Advanced Medical Products, Inc. for the device "SPECTRA ECG". The FDA issued a decision of Substantially Equivalent on June 10, 1992. Advanced Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 1992
Date Received
December 18, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Advanced Medical Products, Inc.

  • K110979 — DERMAGRIP ULTRA POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES NON-STERILE, (October 20, 2011)
  • K000932 — ARACHNOPHLEBECTOMY NEEDLE (May 17, 2000)
  • K923995 — URODYNAMICS TUBING KITS #5161, #5150, #7170 (April 8, 1993)
  • K921426 — ULTRA PCI (October 5, 1992)
  • K912925 — ULTRA PVD (June 18, 1992)
  • K896103 — MICRO FL 7400 AMBULATORY HOLTER/BP MONITOR (January 18, 1990)
  • K896102 — MICRO FD 7000 AMBULATORY BLOOD PRESSURE MONITOR (January 18, 1990)
  • K881905 — MODEL MICRO SI AMBULATORY ECG MONITOR (August 2, 1988)
  • K872508 — MODEL MICRO FD+ AMBULATORY ECG MONITOR (September 25, 1987)
  • K870538 — MODEL 192 PRINTER (April 23, 1987)

Other clearances for product code LOS

  • K090895 — EKG-PLUS II SOFTWARE (August 26, 2009)
  • K083749 — CARDIOVIEW32 REVIEW MODULE (March 10, 2009)
  • K073376 — PHILIPS ECG ALGORITHM (April 11, 2008)
  • K023034 — CARDIOTOUCH-3000 (November 14, 2002)
  • K011328 — CARDIO CARE EKG-2000 12-CHANNEL ELECTROCARDIOGRAPH (November 21, 2001)
  • K993616 — CARDIO-CARD INTERPRETATION SYSTEM I (April 10, 2000)
  • K984465 — OXYCONALPHA WITH OPTION ECG (October 27, 1999)
  • K991014 — CASE 8000 EXERCISE TESTING SYSTEM (October 20, 1999)
  • K991735 — MAC SERIES ELECTROCARDIOGRAPHS INCLUDING MAC 5000, MAC PC, MAC 6, MAC VU, MAC 8 (August 19, 1999)
  • K990031 — NIHON KOHDEN ECG-9010K AND ECG-9020K CARDIOFAX GEM AND ACCESSORIES (April 16, 1999)

FDA data resources