The following data is part of a premarket notification filed by Medipines Corporation with the FDA for Medipines Gas Exchange Monitor (gem), Accessory Mouthpiece Disposable Assembly.
| Device ID | K180902 |
| 510k Number | K180902 |
| Device Name: | MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable Assembly |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | MediPines Corporation 155 N Riverview Drive Anaheim, CA 92808 |
| Contact | Steve Lee |
| Correspondent | Timothy Marcum MediPines Corporation 155 N. Riverview Drive Anaheim Hill, CA 92808 |
| Product Code | CCK |
| Subsequent Product Code | BZL |
| Subsequent Product Code | CCL |
| Subsequent Product Code | DQA |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-06 |
| Decision Date | 2019-01-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860001261530 | K180902 | 000 |
| 00860001261516 | K180902 | 000 |
| 00860001261509 | K180902 | 000 |