510(k) K972136
K972136 is an FDA 510(k) premarket notification submitted by Perkins Mfg. Co. for the device "TV MONITOR (P12/17)". The FDA issued a decision of Substantially Equivalent on June 26, 1997. The device falls under product code IZI (System, X-Ray, Angiographic), a Class II device regulated under 21 CFR 892.1600. Perkins Mfg. Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 26, 1997
- Date Received
- June 6, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Angiographic
- Device Class
- Class II
- Regulation Number
- 892.1600
- Review Panel
- RA
- Submission Type