The following data is part of a premarket notification filed by Precision Medical, Inc. with the FDA for Minimate Compressor.
Device ID | K051691 |
510k Number | K051691 |
Device Name: | MINIMATE COMPRESSOR |
Classification | Compressor, Air, Portable |
Applicant | PRECISION MEDICAL, INC. 300 HELD DR. Northampton, PA 18067 |
Contact | James Parker |
Correspondent | James Parker PRECISION MEDICAL, INC. 300 HELD DR. Northampton, PA 18067 |
Product Code | BTI |
CFR Regulation Number | 868.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-06-23 |
Decision Date | 2005-12-09 |
Summary: | summary |