The following data is part of a premarket notification filed by Ohmeda Medical with the FDA for Ohmeda Model 4700 Oxicap.
Device ID | K911193 |
510k Number | K911193 |
Device Name: | OHMEDA MODEL 4700 OXICAP |
Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
Applicant | OHMEDA MEDICAL 1315 W. LOUISVILLE DR. Louisville, CO 80027 |
Contact | Kevin Morningstar |
Correspondent | Kevin Morningstar OHMEDA MEDICAL 1315 W. LOUISVILLE DR. Louisville, CO 80027 |
Product Code | CCK |
CFR Regulation Number | 868.1400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-03-18 |
Decision Date | 1991-08-02 |