The following data is part of a premarket notification filed by Olympic Medical Corp. with the FDA for Therma-shield.
Device ID | K801461 |
510k Number | K801461 |
Device Name: | THERMA-SHIELD |
Classification | Incubator, Neonatal |
Applicant | OLYMPIC MEDICAL CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | FMZ |
CFR Regulation Number | 880.5400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-06-24 |
Decision Date | 1980-07-28 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
THERMA-SHIELD 98197218 not registered Live/Pending |
Innovative Polymer Systems, LLC 2023-09-26 |
THERMA-SHIELD 74112168 not registered Dead/Abandoned |
Northwest Door, Inc. 1990-11-05 |