The following data is part of a premarket notification filed by Precision Med Products, Ltd. with the FDA for Precision Med Products Ltd Hyperinflation System.
| Device ID | K932709 |
| 510k Number | K932709 |
| Device Name: | PRECISION MED PRODUCTS LTD HYPERINFLATION SYSTEM |
| Classification | Mixer, Breathing Gases, Anesthesia Inhalation |
| Applicant | PRECISION MED PRODUCTS, LTD. 30 ROBB HILL RD. SUITE B Marrtinsville, IN 46151 |
| Contact | Rod Fye |
| Correspondent | Rod Fye PRECISION MED PRODUCTS, LTD. 30 ROBB HILL RD. SUITE B Marrtinsville, IN 46151 |
| Product Code | BZR |
| CFR Regulation Number | 868.5330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-04 |
| Decision Date | 1993-07-23 |