The following data is part of a premarket notification filed by Gould, Inc. with the FDA for Model Im1074 End-tidal Co2 Module.
| Device ID | K843970 |
| 510k Number | K843970 |
| Device Name: | MODEL IM1074 END-TIDAL CO2 MODULE |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | GOULD, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Contact | Archer S Gordon |
| Correspondent | Archer S Gordon GOULD, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-11 |
| Decision Date | 1984-10-24 |