The following data is part of a premarket notification filed by Vitalograph Ltd. with the FDA for Vitalograph Function Analyzer.
Device ID | K791503 |
510k Number | K791503 |
Device Name: | VITALOGRAPH FUNCTION ANALYZER |
Classification | Calculator, Pulmonary Function Data |
Applicant | VITALOGRAPH LTD. 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 | 1979-08-08 |
Decision Date | 1979-08-16 |