The following data is part of a premarket notification filed by Ohmeda Medical with the FDA for Ohmeda 3800 Pulse Oximeter.
| Device ID | K962127 |
| 510k Number | K962127 |
| Device Name: | OHMEDA 3800 PULSE OXIMETER |
| Classification | Oximeter |
| Applicant | OHMEDA MEDICAL OHMEDA DRIVE, P.O. BOX 7550 Madison, WI 53707 -7550 |
| Contact | Charles Morreale |
| Correspondent | Charles Morreale OHMEDA MEDICAL OHMEDA DRIVE, P.O. BOX 7550 Madison, WI 53707 -7550 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-03 |
| Decision Date | 1996-10-10 |
| Summary: | summary |