510(k) K811956
K811956 is an FDA 510(k) premarket notification submitted by Autonomic Equipment Supply Co, for the device "AUTONORM & NERV-A-NORM". The FDA issued a decision of Substantially Equivalent on July 31, 1981. The device falls under product code KNM (Device, Pressure Applying), a Class I device regulated under 21 CFR 890.5765. Autonomic Equipment Supply Co, has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 31, 1981
- Date Received
- July 9, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Pressure Applying
- Device Class
- Class I
- Regulation Number
- 890.5765
- Review Panel
- PM
- Submission Type