The following data is part of a premarket notification filed by Medica Corp. with the FDA for Easyblood Gas Analyzer.
| Device ID | K974526 |
| 510k Number | K974526 |
| Device Name: | EASYBLOOD GAS ANALYZER |
| Classification | Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph |
| Applicant | MEDICA CORP. 14 DEANGELO DR. Bedford, MA 01730 |
| Contact | Photios Makris |
| Correspondent | Photios Makris MEDICA CORP. 14 DEANGELO DR. Bedford, MA 01730 |
| Product Code | CHL |
| CFR Regulation Number | 862.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-02 |
| Decision Date | 1998-02-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00386100002329 | K974526 | 000 |
| 00386100002312 | K974526 | 000 |
| 00386100002305 | K974526 | 000 |
| 00386100002299 | K974526 | 000 |
| 00630414452319 | K974526 | 000 |