The following data is part of a premarket notification filed by Parvo Medics, Inc. with the FDA for Mms-2400.
Device ID | K941843 |
510k Number | K941843 |
Device Name: | MMS-2400 |
Classification | Calculator, Pulmonary Function Data |
Applicant | PARVO MEDICS, INC. 1148 CHARLTON AVE. Salt Lake City, UT 84106 |
Contact | Robert L Jensen |
Correspondent | Robert L Jensen PARVO MEDICS, INC. 1148 CHARLTON AVE. Salt Lake City, UT 84106 |
Product Code | BZC |
CFR Regulation Number | 868.1880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-04-14 |
Decision Date | 1995-06-16 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
B687MMS240005 | K941843 | 000 |