510(k) K812564
K812564 is an FDA 510(k) premarket notification submitted by Zee Medical Products Co., Inc. for the device "ZEE LIFE SUPPORT AIR PANTS". The FDA issued a decision of Substantially Equivalent on October 23, 1981. The device falls under product code LHX (Trousers, Anti-Shock), a Class II device regulated under 21 CFR 870.5800. Zee Medical Products Co., Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 23, 1981
- Date Received
- September 8, 1981
- 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