The following data is part of a premarket notification filed by Bp Medical Systems, Inc. with the FDA for Bp Trauma Air Pants.
Device ID | K841605 |
510k Number | K841605 |
Device Name: | BP TRAUMA AIR PANTS |
Classification | Trousers, Anti-shock |
Applicant | BP MEDICAL SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | LHX |
CFR Regulation Number | 870.5800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-04-19 |
Decision Date | 1984-07-06 |