510(k) K821401
K821401 is an FDA 510(k) premarket notification submitted by Forma Scientific, Inc. for the device "MALLINCKRODT DIAG. MEDIA WARMER". The FDA issued a decision of Substantially Equivalent on June 17, 1982. The device falls under product code DXT (Injector And Syringe, Angiographic), a Class II device regulated under 21 CFR 870.1650. Forma Scientific, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 17, 1982
- Date Received
- May 11, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Injector And Syringe, Angiographic
- Device Class
- Class II
- Regulation Number
- 870.1650
- Review Panel
- HO
- Submission Type