The following data is part of a premarket notification filed by Ackrad Laboratories with the FDA for Ackrad Esophageal Balloon Catheter Set.
| Device ID | K952542 |
| 510k Number | K952542 |
| Device Name: | ACKRAD ESOPHAGEAL BALLOON CATHETER SET |
| Classification | Calculator, Pulmonary Function Data |
| Applicant | ACKRAD LABORATORIES 70 JACKSON DR. Cranford, NJ 07016 |
| Contact | Robert M Landis |
| Correspondent | Robert M Landis ACKRAD LABORATORIES 70 JACKSON DR. Cranford, NJ 07016 |
| Product Code | BZC |
| CFR Regulation Number | 868.1880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-23 |
| Decision Date | 1996-04-23 |