The following data is part of a premarket notification filed by Spirometrics, Inc. with the FDA for Co/cmd-1.
| Device ID | K900322 |
| 510k Number | K900322 |
| Device Name: | CO/CMD-1 |
| Classification | Analyzer, Gas, Carbon-monoxide, Gaseous-phase |
| Applicant | SPIROMETRICS, INC. 33 OMNI CIRCLE Auburn, ME 04210 -1210 |
| Contact | Ann Therriault |
| Correspondent | Ann Therriault SPIROMETRICS, INC. 33 OMNI CIRCLE Auburn, ME 04210 -1210 |
| Product Code | CCJ |
| CFR Regulation Number | 868.1430 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-23 |
| Decision Date | 1990-04-30 |