The following data is part of a premarket notification filed by Collins Medical, Inc. with the FDA for Collins Cpl.
| Device ID | K992743 |
| 510k Number | K992743 |
| Device Name: | COLLINS CPL |
| Classification | Spirometer, Diagnostic |
| Applicant | COLLINS MEDICAL, INC. 220 WOOD RD. Braintree, MA 02184 -2408 |
| Contact | Dale F Hubbard |
| Correspondent | Dale F Hubbard COLLINS MEDICAL, INC. 220 WOOD RD. Braintree, MA 02184 -2408 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-16 |
| Decision Date | 1999-09-13 |