The following data is part of a premarket notification filed by I-stat Corp. with the FDA for I-stat Tests For Acid-base Parameters.
| Device ID | K936081 |
| 510k Number | K936081 |
| Device Name: | I-STAT TESTS FOR ACID-BASE PARAMETERS |
| Classification | Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph |
| Applicant | I-STAT CORP. 436 HAZELDEAN ROAD KANATA Ontario K2l 1t9, Canada, CA |
| Contact | Imants R Lauks |
| Correspondent | Imants R Lauks I-STAT CORP. 436 HAZELDEAN ROAD KANATA Ontario K2l 1t9, Canada, CA |
| Product Code | CHL |
| CFR Regulation Number | 862.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-21 |
| Decision Date | 1994-02-24 |