The following data is part of a premarket notification filed by Radiometer America, Inc. with the FDA for Oximeter.
| Device ID | K871353 |
| 510k Number | K871353 |
| Device Name: | OXIMETER |
| Classification | Oximeter |
| Applicant | RADIOMETER AMERICA, INC. 811 SHARON DR. Westlake, OH 44145 -1598 |
| Contact | Martin A Miller |
| Correspondent | Martin A Miller RADIOMETER AMERICA, INC. 811 SHARON DR. Westlake, OH 44145 -1598 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-06 |
| Decision Date | 1987-06-08 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() OXIMETER 86730853 not registered Dead/Abandoned |
Pearl Enterprises LLC 2015-08-20 |