The following data is part of a premarket notification filed by Medica Corp. with the FDA for Easystat Ph, Pco2, Po2, Hct, Na+, K+, Ca++ Analyzer.
| Device ID | K021515 |
| 510k Number | K021515 |
| Device Name: | EASYSTAT PH, PCO2, PO2, HCT, NA+, K+, CA++ ANALYZER |
| Classification | Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph |
| Applicant | MEDICA CORP. 14 DEANGELO DR. Bedford, MA 01730 |
| Contact | Dean Honkonen |
| Correspondent | Dean Honkonen MEDICA CORP. 14 DEANGELO DR. Bedford, MA 01730 |
| Product Code | CHL |
| Subsequent Product Code | CEM |
| Subsequent Product Code | GKF |
| Subsequent Product Code | JFP |
| Subsequent Product Code | JGS |
| CFR Regulation Number | 862.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-10 |
| Decision Date | 2002-07-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00386100003739 | K021515 | 000 |
| 00630414566313 | K021515 | 000 |
| 00630414566306 | K021515 | 000 |
| 00630414566290 | K021515 | 000 |
| 00630414566269 | K021515 | 000 |
| 00630414566252 | K021515 | 000 |
| 00630414566245 | K021515 | 000 |
| 00630414566238 | K021515 | 000 |
| 00630414566221 | K021515 | 000 |
| 00630414566337 | K021515 | 000 |
| 00630414566771 | K021515 | 000 |
| 00386100002664 | K021515 | 000 |
| 00386100002633 | K021515 | 000 |
| 00386100002602 | K021515 | 000 |
| 00386100002596 | K021515 | 000 |
| 00386100002466 | K021515 | 000 |
| 00386100002459 | K021515 | 000 |
| 00386100002398 | K021515 | 000 |
| 00630414568584 | K021515 | 000 |
| 00630414452074 | K021515 | 000 |