510(k) K162562
K162562 is an FDA 510(k) premarket notification submitted by Bcg Medical, LLC for the device "OPT-SHIELD AIR, SUPINE; OPT-SHIELD, LITHOTOMY". The FDA issued a decision of Substantially Equivalent on Mar 17, 2017. The device falls under product code DWJ (System, Thermal Regulating), a Class II device regulated under 21 CFR 870.5900.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 17, 2017
- Date Received
- Sep 14, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Thermal Regulating
- Device Class
- Class II
- Regulation Number
- 870.5900
- Review Panel
- CV
- Submission Type
- 510(k)
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).