The following data is part of a premarket notification filed by Collins Medical, Inc. with the FDA for Gem, Model 004110.
| Device ID | K030464 |
| 510k Number | K030464 |
| Device Name: | GEM, MODEL 004110 |
| Classification | Spirometer, Diagnostic |
| Applicant | COLLINS MEDICAL, INC. 220 WOOD RD. Braintree, MA 02184 -2408 |
| Contact | Donald Henton |
| Correspondent | Donald Henton 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 | 2003-02-12 |
| Decision Date | 2003-03-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852417003408 | K030464 | 000 |