The following data is part of a premarket notification filed by Spirometrics Medical Equipment Co. with the FDA for Flowmate Ii Plus, Model #4000.
| Device ID | K982956 |
| 510k Number | K982956 |
| Device Name: | FLOWMATE II PLUS, MODEL #4000 |
| Classification | Spirometer, Diagnostic |
| Applicant | SPIROMETRICS MEDICAL EQUIPMENT CO. 415 RODMAN RD. Auburn, ME 04210 |
| Contact | Donald Henton |
| Correspondent | Donald Henton SPIROMETRICS MEDICAL EQUIPMENT CO. 415 RODMAN RD. Auburn, ME 04210 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-24 |
| Decision Date | 1998-11-24 |
| Summary: | summary |