510(k) K862628
K862628 is an FDA 510(k) premarket notification submitted by The John Bunn Co. for the device "BUNN MODEL 510 MEDICATION COMPRESSOR". The FDA issued a decision of Substantially Equivalent on August 7, 1986. The device falls under product code BTI (Compressor, Air, Portable), a Class II device regulated under 21 CFR 868.6250. The John Bunn Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 7, 1986
- Date Received
- July 10, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Compressor, Air, Portable
- Device Class
- Class II
- Regulation Number
- 868.6250
- Review Panel
- AN
- Submission Type