Medical Device Manufacturer · US , Milton , WI

Burdick, Inc. - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 1994

Recent clearances: QUEST EXERCISE STRESS SYSTEM, BURDICK 200 PULSE OXIMETER, ECLIPSE 4 ELECTROCARDIOGRAPH

6

Total

6

Cleared

0

Denied

FDA 510(k) Regulatory Record - Burdick, Inc. Cardiovascular ✕

5 devices

1-5 of 5

Cleared May 22, 1996

QUEST EXERCISE STRESS SYSTEM

Cardiovascular · 365d

Cleared Apr 23, 1996

ECLIPSE 4 ELECTROCARDIOGRAPH

Cardiovascular · 483d

Cleared Jul 03, 1995

PC HOLTER SCANNING SYSTEM SIMPLICITY, ALTAIR 8200, 8300, 8400

Cardiovascular · 207d

Cleared May 17, 1995

ECLIPSE 4 ELECTROCARDIOGRAPH

Cardiovascular · 275d

Cleared Aug 05, 1994

ALTAIR 6100 CASSETTE RECORDER

Cardiovascular · 77d