The following data is part of a premarket notification filed by I-stat Corp. with the FDA for I-stat 200 Portable Clinical Analyzer.
| Device ID | K940918 |
| 510k Number | K940918 |
| Device Name: | I-STAT 200 PORTABLE CLINICAL ANALYZER |
| Classification | Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph |
| Applicant | I-STAT CORP. 303 COLLEGE RD. EAST Princeton, NJ 08540 |
| Contact | Imants R Lauks |
| Correspondent | Imants R Lauks I-STAT CORP. 303 COLLEGE RD. EAST Princeton, NJ 08540 |
| Product Code | CHL |
| CFR Regulation Number | 862.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-02-25 |
| Decision Date | 1994-05-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10054749000163 | K940918 | 000 |
| 10054749000071 | K940918 | 000 |
| 10054749000064 | K940918 | 000 |
| 10054749000057 | K940918 | 000 |
| 10054749000040 | K940918 | 000 |