The following data is part of a premarket notification filed by Spirometrics, Inc. with the FDA for Spirometrics 2451 & Smi I.
| Device ID | K844333 |
| 510k Number | K844333 |
| Device Name: | SPIROMETRICS 2451 & SMI I |
| Classification | Spirometer, Diagnostic |
| Applicant | SPIROMETRICS, INC. 26 ESSEX ST. Andover, MA 01810 |
| Contact | Noel G Wray |
| Correspondent | Noel G Wray SPIROMETRICS, INC. 26 ESSEX ST. Andover, MA 01810 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-07 |
| Decision Date | 1984-11-20 |