The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Meridian Medical Systems Breathing Filter.
Device ID | K925217 |
510k Number | K925217 |
Device Name: | MERIDIAN MEDICAL SYSTEMS BREATHING FILTER |
Classification | Filter, Bacterial, Breathing-circuit |
Applicant | MERIT MEDICAL SYSTEMS, INC. 8102 WOODLAND DR/. Indianapolis, IN 46278 |
Contact | Robert Richmond |
Correspondent | Robert Richmond MERIT MEDICAL SYSTEMS, INC. 8102 WOODLAND DR/. Indianapolis, IN 46278 |
Product Code | CAH |
CFR Regulation Number | 868.5260 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-10-16 |
Decision Date | 1993-01-26 |