510(k) K841605
K841605 is an FDA 510(k) premarket notification submitted by Bp Medical Systems, Inc. for the device "BP TRAUMA AIR PANTS". The FDA issued a decision of Substantially Equivalent on July 6, 1984. The device falls under product code LHX (Trousers, Anti-Shock), a Class II device regulated under 21 CFR 870.5800.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 6, 1984
- Date Received
- April 19, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Trousers, Anti-Shock
- Device Class
- Class II
- Regulation Number
- 870.5800
- Review Panel
- CV
- Submission Type