The following data is part of a premarket notification filed by Precision Med Products, Ltd. with the FDA for Precision Med Products, Ltd. Adult Gas Sampling.
Device ID | K932497 |
510k Number | K932497 |
Device Name: | PRECISION MED PRODUCTS, LTD. ADULT GAS SAMPLING |
Classification | Circuit, Breathing (w Connector, Adaptor, Y Piece) |
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 | CAI |
CFR Regulation Number | 868.5240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-05-24 |
Decision Date | 1993-07-22 |