The following data is part of a premarket notification filed by Warren E. Collins, Inc. with the FDA for Collins Digital Pulmonary Manometer.
| Device ID | K912946 |
| 510k Number | K912946 |
| Device Name: | COLLINS DIGITAL PULMONARY MANOMETER |
| Classification | Meter, Airway Pressure (inspiratory Force) |
| Applicant | WARREN E. COLLINS, INC. 220 WOOD RD. Braintree, MA 02184 -2408 |
| Contact | James J Tully |
| Correspondent | James J Tully WARREN E. COLLINS, INC. 220 WOOD RD. Braintree, MA 02184 -2408 |
| Product Code | BXR |
| CFR Regulation Number | 868.1780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-05 |
| Decision Date | 1992-01-15 |