The following data is part of a premarket notification filed by Precision Med Products, Ltd. with the FDA for Pmp, Ltd. Pediatric Temperature Monitoring Circuit.
Device ID | K932486 |
510k Number | K932486 |
Device Name: | PMP, LTD. PEDIATRIC TEMPERATURE MONITORING CIRCUIT |
Classification | Circuit, Breathing (w Connector, Adaptor, Y Piece) |
Applicant | PRECISION MED PRODUCTS, LTD. 30 ROBB HILL RD. SUITE B Marrtinsville, IN 46151 |
Contact | Rob Fye |
Correspondent | Rob 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 | 1993-07-21 |