The following data is part of a premarket notification filed by Moor Instruments Ltd. with the FDA for Moorvms-pres Pressure Cuff Controller.
| Device ID | K102433 |
| 510k Number | K102433 |
| Device Name: | MOORVMS-PRES PRESSURE CUFF CONTROLLER |
| Classification | Flowmeter, Blood, Cardiovascular |
| Applicant | MOOR INSTRUMENTS LTD. MILLWEY Axminster, Devon, GB Ex135hu |
| Contact | Xiabing Huang |
| Correspondent | Xiabing Huang MOOR INSTRUMENTS LTD. MILLWEY Axminster, Devon, GB Ex135hu |
| Product Code | DPW |
| CFR Regulation Number | 870.2100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-26 |
| Decision Date | 2010-11-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15060484490010 | K102433 | 000 |