The following data is part of a premarket notification filed by Oricare, Inc. with the FDA for Medical Air Compressor.
Device ID | K113338 |
510k Number | K113338 |
Device Name: | MEDICAL AIR COMPRESSOR |
Classification | Compressor, Air, Portable |
Applicant | ORICARE, INC. 1900 AM DRIVE Quakertown, PA 18951 |
Contact | David Jamison |
Correspondent | David Jamison ORICARE, INC. 1900 AM DRIVE Quakertown, PA 18951 |
Product Code | BTI |
CFR Regulation Number | 868.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-11-14 |
Decision Date | 2012-08-10 |
Summary: | summary |