The following data is part of a premarket notification filed by Guangdong Biolight Meditech Co., Ltd with the FDA for Any View Patient Monitors.
| Device ID | K120193 |
| 510k Number | K120193 |
| Device Name: | ANY VIEW PATIENT MONITORS |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | GUANGDONG BIOLIGHT MEDITECH CO., LTD P.O. BOX 237-023 Shanghai, CN 200237 |
| Contact | Diana Hong |
| Correspondent | Diana Hong GUANGDONG BIOLIGHT MEDITECH CO., LTD P.O. BOX 237-023 Shanghai, CN 200237 |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-23 |
| Decision Date | 2012-06-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852503007167 | K120193 | 000 |