The following data is part of a premarket notification filed by Ohmeda Medical with the FDA for Ohmeda Hand Held Oximeter.
Device ID | K931304 |
510k Number | K931304 |
Device Name: | OHMEDA HAND HELD OXIMETER |
Classification | Oximeter |
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 | DQA |
CFR Regulation Number | 870.2700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-03-15 |
Decision Date | 1994-09-29 |