The following data is part of a premarket notification filed by Mennen Medical, Inc. with the FDA for Horizon 2000 Pulse Oximetry And Module.
| Device ID | K882273 |
| 510k Number | K882273 |
| Device Name: | HORIZON 2000 PULSE OXIMETRY AND MODULE |
| Classification | Oximeter |
| Applicant | MENNEN MEDICAL, INC. 10123 MAIN ST. Clarence, NY 14031 |
| Contact | Thomas W Connelly |
| Correspondent | Thomas W Connelly MENNEN MEDICAL, INC. 10123 MAIN ST. Clarence, NY 14031 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-05-31 |
| Decision Date | 1988-08-25 |