The following data is part of a premarket notification filed by Fluke Biomedical with the FDA for Prosim 4, Prosim 6, Prosim 8.
| Device ID | K110429 |
| 510k Number | K110429 |
| Device Name: | PROSIM 4, PROSIM 6, PROSIM 8 |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Applicant | FLUKE BIOMEDICAL 6045 COCHRAN RD. Solon, OH 44139 |
| Contact | John Nelson |
| Correspondent | John Nelson FLUKE BIOMEDICAL 6045 COCHRAN RD. Solon, OH 44139 |
| Product Code | DRT |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-15 |
| Decision Date | 2011-09-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850540007102 | K110429 | 000 |
| 00850540007096 | K110429 | 000 |
| 00850540007089 | K110429 | 000 |
| 00850540007072 | K110429 | 000 |
| 00850540007065 | K110429 | 000 |