510(k) K914184
K914184 is an FDA 510(k) premarket notification submitted by Precise Optics for the device "P2020-8-0 BEAM-LIMITING DEVICE". The FDA issued a decision of Substantially Equivalent on Nov 27, 1991. The device falls under product code KPW (Device, Beam Limiting, X-Ray, Diagnostic), a Class II device regulated under 21 CFR 892.1610. Precise Optics has 12 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 27, 1991
- Date Received
- Sep 18, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Beam Limiting, X-Ray, Diagnostic
- Device Class
- Class II
- Regulation Number
- 892.1610
- Review Panel
- RA
- Submission Type
- 510(k) Exempt