510(k) K780312
K780312 is an FDA 510(k) premarket notification submitted by Autonomic Equipment Supply Co, for the device "AUTONOM". The FDA issued a decision of Substantially Equivalent on April 5, 1978. 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
- April 5, 1978
- Date Received
- February 15, 1978
- 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