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510(k) K900729

NEOSERV 824 by Burdick Corp. — Product Code MCJ

K900729 is an FDA 510(k) premarket notification submitted by Burdick Corp. for the device "NEOSERV 824". The FDA issued a decision of Substantially Equivalent on June 8, 1990. Burdick Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 8, 1990
Date Received
February 15, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Burdick Corp.

  • K952417 — QUEST EXERCISE STRESS SYSTEM (May 22, 1996)
  • K954267 — BURDICK 200 PULSE OXIMETER (May 3, 1996)
  • K946281 — ECLIPSE 4 ELECTROCARDIOGRAPH (April 23, 1996)
  • K945985 — PC HOLTER SCANNING SYSTEM SIMPLICITY, ALTAIR 8200, 8300, 8400 (July 3, 1995)
  • K943959 — ECLIPSE 4 ELECTROCARDIOGRAPH (May 17, 1995)
  • K942565 — ALTAIR-DISC RECORDER (December 5, 1994)
  • K941351 — BURDICK PRO2 OXIMETER (October 13, 1994)
  • K942438 — ALTAIR 6100 CASSETTE RECORDER (August 5, 1994)
  • K904032 — ELITE II ELECTROCARDIOGRAPH (July 24, 1991)
  • K903565 — E560 ELECTROCARDIOGRAPH (July 24, 1991)

FDA data resources