The following data is part of a premarket notification filed by Respirizer Co., Div. Campillary Systems, Inc. with the FDA for Respirizer.
Device ID | K810335 |
510k Number | K810335 |
Device Name: | RESPIRIZER |
Classification | Humidifier, Non-direct Patient Interface (home-use) |
Applicant | RESPIRIZER CO., DIV. CAMPILLARY SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KFZ |
CFR Regulation Number | 868.5460 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-02-09 |
Decision Date | 1981-03-20 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
RESPIRIZER 73082628 1062151 Dead/Expired |
CAMPILLARY SYSTEMS INC. 1976-04-05 |