The following data is part of a premarket notification filed by Bcg Medical, Llc with the FDA for Opt-shield Air, Supine; Opt-shield, Lithotomy.
| Device ID | K162562 |
| 510k Number | K162562 |
| Device Name: | OPT-SHIELD AIR, SUPINE; OPT-SHIELD, LITHOTOMY |
| Classification | System, Thermal Regulating |
| Applicant | BCG MEDICAL, LLC 6715 RANCHO TOYON PLACE San Diego, CA 92130 |
| Contact | Lisa Giap |
| Correspondent | Lisa Giap BCG MEDICAL, LLC 6715 RANCHO TOYON PLACE San Diego, CA 92130 |
| Product Code | DWJ |
| CFR Regulation Number | 870.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-14 |
| Decision Date | 2017-03-17 |