The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Mass Spectrometry Monitoring Line Cononectors.
| Device ID | K925167 |
| 510k Number | K925167 |
| Device Name: | MASS SPECTROMETRY MONITORING LINE CONONECTORS |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | MERIT MEDICAL SYSTEMS, INC. 8102 WOODLAND DR/. Indianapolis, IN 46278 |
| Contact | Robert Ricmond |
| Correspondent | Robert Ricmond MERIT MEDICAL SYSTEMS, INC. 8102 WOODLAND DR/. Indianapolis, IN 46278 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-13 |
| Decision Date | 1993-01-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888277362604 | K925167 | 000 |