The following data is part of a premarket notification filed by Vitalograph Ltd. with the FDA for Vitalograph-ec60 Hydrogen Monitor.
Device ID | K874892 |
510k Number | K874892 |
Device Name: | VITALOGRAPH-EC60 HYDROGEN MONITOR |
Classification | System, Breath Measurement |
Applicant | VITALOGRAPH LTD. 8347 QUIVIRA RD. Lenexa, KS 66215 |
Contact | Lovina G Freeman |
Correspondent | Lovina G Freeman VITALOGRAPH LTD. 8347 QUIVIRA RD. Lenexa, KS 66215 |
Product Code | NRH |
CFR Regulation Number | 862.1820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-12-01 |
Decision Date | 1988-06-02 |