The following data is part of a premarket notification filed by Cmi Health Inc. with the FDA for Capnograph And Oximeter.
| Device ID | K170820 |
| 510k Number | K170820 |
| Device Name: | Capnograph And Oximeter |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | CMI Health Inc. 5975 Shiloh Road, Suite 114 Alpharetta, GA 30005 |
| Contact | Jiacheng Ren |
| Correspondent | Charles Mack International Regulatory Consulting 7808 Rush Creek Drive Pasco, WA 99301 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-20 |
| Decision Date | 2018-07-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850000967007 | K170820 | 000 |
| 00817698020032 | K170820 | 000 |