FDA 510(k), K952542, ACKRAD ESOPHAGEAL BALLOON CATHETER SET

510(K) Number: K952542
Device Name: ACKRAD ESOPHAGEAL BALLOON CATHETER SET
Manufacturer: ACKRAD LABORATORIES
Device Classification Name: Calculator, Pulmonary Function Data
Regulation Number: 868.1880
Classification Product Code: BZC
Date Received: 05/23/1995
Decision Date: 04/23/1996
Regulation Medical Specialty: Anesthesiology

114 pages (39 of 153 original pages are fully redacted)