510(k) K854817
K854817 is an FDA 510(k) premarket notification submitted by Teledyne, Inc. for the device "INSTAPURE". The FDA issued a decision of Substantially Equivalent on February 28, 1986. The device falls under product code FRF (Cleaner, Air, Medical Recirculating), a Class II device regulated under 21 CFR 880.5045. Teledyne, Inc. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 28, 1986
- Date Received
- December 3, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cleaner, Air, Medical Recirculating
- Device Class
- Class II
- Regulation Number
- 880.5045
- Review Panel
- HO
- Submission Type