Home / 510(k) Clearances / K822626

510(k) K822626

ATC BIOELECTROGRAPHIC MONITOR MODEL I. by Advantage Medical Systems, Inc.

K822626 is an FDA 510(k) premarket notification submitted by Advantage Medical Systems, Inc. for the device "ATC BIOELECTROGRAPHIC MONITOR MODEL I.". The FDA issued a decision of Substantially Equivalent on September 15, 1982. Advantage Medical Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 1982
Date Received
September 2, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Advantage Medical Systems, Inc.

  • K873957 — NON-CORING HUBER TYPE NEEDLES (October 23, 1987)
  • K873290 — LACERATION AND INSTRUMENT TRAYS (September 24, 1987)
  • K863494 — NEONATAL PHYSIOLOGICAL MONITOR MODEL PM 20 (December 22, 1986)
  • K861556 — MODIFIED FETAL MONITOR MODEL FM-2 (July 7, 1986)
  • K861279 — FLUORO PLUS (June 16, 1986)
  • K861455 — MODEL DT-102 DATA TELEPHONE TRANSMITTER (May 30, 1986)
  • K852518 — MODIFICATION FETAL MONITOR MODEL FM-2 (July 5, 1985)
  • K844724 — FETAL TELEMETRY SYSTEM (May 1, 1985)
  • K842462 — HOLTER SCREENING MONITOR HS-221 (September 11, 1984)
  • K840747 — TOCO DATA TELEPHONE TRANSMITTER DT100P (June 19, 1984)

FDA data resources