The following data is part of a premarket notification filed by Electronics For Medicine, Inc. with the FDA for Model V 4207 Integrating Plug-in.
Device ID | K790185 |
510k Number | K790185 |
Device Name: | MODEL V 4207 INTEGRATING PLUG-IN |
Classification | Calculator, Pulmonary Function Data |
Applicant | ELECTRONICS FOR MEDICINE, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | BZC |
CFR Regulation Number | 868.1880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-01-29 |
Decision Date | 1979-02-16 |