The following data is part of a premarket notification filed by Wr Medical Electronics Co. with the FDA for Hrv Acquire.
| Device ID | K092809 |
| 510k Number | K092809 |
| Device Name: | HRV ACQUIRE |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Applicant | WR MEDICAL ELECTRONICS CO. 800 LAVANGER LANE Stoughton, WI 53589 |
| Contact | Gary Syring |
| Correspondent | Gary Syring WR MEDICAL ELECTRONICS CO. 800 LAVANGER LANE Stoughton, WI 53589 |
| Product Code | DRT |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-11 |
| Decision Date | 2010-10-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00702173456508 | K092809 | 000 |