The following data is part of a premarket notification filed by Caradyne, Ltd. with the FDA for Oxicheck.
| Device ID | K023565 |
| 510k Number | K023565 |
| Device Name: | OXICHECK |
| Classification | Analyzer, Gas, Oxygen, Gaseous-phase |
| Applicant | CARADYNE, LTD. 6329 W. WATERVIEW CT. Mccordsville, IN 46055 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden CARADYNE, LTD. 6329 W. WATERVIEW CT. Mccordsville, IN 46055 |
| Product Code | CCL |
| CFR Regulation Number | 868.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-23 |
| Decision Date | 2003-03-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838083189 | K023565 | 000 |