The following data is part of a premarket notification filed by Thayer Medical Corp. with the FDA for Thayer Mip Adapter.
Device ID | K904917 |
510k Number | K904917 |
Device Name: | THAYER MIP ADAPTER |
Classification | Meter, Airway Pressure (inspiratory Force) |
Applicant | THAYER MEDICAL CORP. 8141 E. MCLAREN P.O. BOX 57907 Tucson, AZ 85715 |
Contact | David Sladek |
Correspondent | David Sladek THAYER MEDICAL CORP. 8141 E. MCLAREN P.O. BOX 57907 Tucson, AZ 85715 |
Product Code | BXR |
CFR Regulation Number | 868.1780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-10-31 |
Decision Date | 1991-01-28 |