The following data is part of a premarket notification filed by Dade Intl., Inc. with the FDA for Dade Indirect Imt System With Tco2 Electrode.
| Device ID | K970330 |
| 510k Number | K970330 |
| Device Name: | DADE INDIRECT IMT SYSTEM WITH TCO2 ELECTRODE |
| Classification | Electrode, Ion Specific, Potassium |
| Applicant | DADE INTL., INC. BUILDING 500, MAILBOX 514 P.O. BOX 6101 Newark, DE 19714 -6101 |
| Contact | Carolyn K George |
| Correspondent | Carolyn K George DADE INTL., INC. BUILDING 500, MAILBOX 514 P.O. BOX 6101 Newark, DE 19714 -6101 |
| Product Code | CEM |
| Subsequent Product Code | CGZ |
| Subsequent Product Code | JFL |
| Subsequent Product Code | JGS |
| CFR Regulation Number | 862.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-28 |
| Decision Date | 1997-04-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768014307 | K970330 | 000 |
| 00842768014024 | K970330 | 000 |
| 00842768014017 | K970330 | 000 |