The following data is part of a premarket notification filed by Precision Med Products, Ltd. with the FDA for Precision Med Products Ltd. Ventilator Hose.
Device ID | K932706 |
510k Number | K932706 |
Device Name: | PRECISION MED PRODUCTS LTD. VENTILATOR HOSE |
Classification | Set, Tubing And Support, Ventilator (w Harness) |
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 | BZO |
CFR Regulation Number | 868.5975 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-06-04 |
Decision Date | 1993-07-23 |