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 |