The following data is part of a premarket notification filed by Radiometer America, Inc. with the FDA for Oximeter.
Device ID | K893587 |
510k Number | K893587 |
Device Name: | OXIMETER |
Classification | Oximeter |
Applicant | RADIOMETER AMERICA, INC. 811 SHARON DR. Westlake, OH 44145 -1598 |
Contact | Donald L Baker |
Correspondent | Donald L Baker 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 | 1989-05-09 |
Decision Date | 1989-09-05 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
OXIMETER 86730853 not registered Dead/Abandoned |
Pearl Enterprises LLC 2015-08-20 |