The following data is part of a premarket notification filed by Vacumed, Div. Of Vacumetrics, Inc. with the FDA for Vacu*med, Gold Edition Carbon Dioxide Gas Analyzer.
| Device ID | K973544 |
| 510k Number | K973544 |
| Device Name: | VACU*MED, GOLD EDITION CARBON DIOXIDE GAS ANALYZER |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | VACUMED, DIV. OF VACUMETRICS, INC. 2225 EAST MURRAY HOLLADAY RD. SUITE 207 Salt Lake City, UT 84117 |
| Contact | Jacquiline E Frailey |
| Correspondent | Jacquiline E Frailey VACUMED, DIV. OF VACUMETRICS, INC. 2225 EAST MURRAY HOLLADAY RD. SUITE 207 Salt Lake City, UT 84117 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-18 |
| Decision Date | 1998-05-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850644007008 | K973544 | 000 |