The following data is part of a premarket notification filed by Reavillmed with the FDA for Reavillmed Pressure Monitoring System And Picc.
| Device ID | K101189 |
| 510k Number | K101189 |
| Device Name: | REAVILLMED PRESSURE MONITORING SYSTEM AND PICC |
| Classification | Transducer, Blood-pressure, Extravascular |
| Applicant | REAVILLMED 888 E. BELVIDERE ROAD SUITE 212 Grayslake, IL 60030 |
| Contact | Michele H Vovolka |
| Correspondent | Michele H Vovolka REAVILLMED 888 E. BELVIDERE ROAD SUITE 212 Grayslake, IL 60030 |
| Product Code | DRS |
| CFR Regulation Number | 870.2850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-28 |
| Decision Date | 2010-12-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00863523000304 | K101189 | 000 |