The following data is part of a premarket notification filed by Precision Medical, Inc. with the FDA for Precision Medical Disposable Humidifier.
| Device ID | K902970 |
| 510k Number | K902970 |
| Device Name: | PRECISION MEDICAL DISPOSABLE HUMIDIFIER |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | PRECISION MEDICAL, INC. 7285 PARK DR. Bath, PA 18014 |
| Contact | John R Selady |
| Correspondent | John R Selady PRECISION MEDICAL, INC. 7285 PARK DR. Bath, PA 18014 |
| Product Code | BTT |
| CFR Regulation Number | 868.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-06 |
| Decision Date | 1990-08-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00855887006924 | K902970 | 000 |