The following data is part of a premarket notification filed by Pneumedics, Inc. with the FDA for Spiroloop, Modification.
| Device ID | K904633 |
| 510k Number | K904633 |
| Device Name: | SPIROLOOP, MODIFICATION |
| Classification | Analyzer, Gas, Carbon-monoxide, Gaseous-phase |
| Applicant | PNEUMEDICS, INC. 291 PEPE'S FRAM RD. Milford, CT 06460 |
| Contact | Richard P Imbruce |
| Correspondent | Richard P Imbruce PNEUMEDICS, INC. 291 PEPE'S FRAM RD. Milford, CT 06460 |
| Product Code | CCJ |
| CFR Regulation Number | 868.1430 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-25 |
| Decision Date | 1991-03-12 |