The following data is part of a premarket notification filed by Moor Instruments Ltd. with the FDA for Noorvms-oxy Tissue Oxygen And Temperture Monitor.
| Device ID | K112826 |
| 510k Number | K112826 |
| Device Name: | NOORVMS-OXY TISSUE OXYGEN AND TEMPERTURE MONITOR |
| Classification | Oximeter, Tissue Saturation |
| Applicant | MOOR INSTRUMENTS LTD. MILLWEY Axminster, Devon, GB Ex135hu |
| Contact | Xiabing Huang Huang |
| Correspondent | Xiabing Huang Huang MOOR INSTRUMENTS LTD. MILLWEY Axminster, Devon, GB Ex135hu |
| Product Code | MUD |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-28 |
| Decision Date | 2012-10-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15060484490140 | K112826 | 000 |
| 15060484490027 | K112826 | 000 |