The following data is part of a premarket notification filed by Vitalograph Ltd. with the FDA for Vitalograph Ec-50 Carbon Monoxide Monitor.
Device ID | K863420 |
510k Number | K863420 |
Device Name: | VITALOGRAPH EC-50 CARBON MONOXIDE MONITOR |
Classification | Analyzer, Gas, Carbon-monoxide, Gaseous-phase |
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 | CCJ |
CFR Regulation Number | 868.1430 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-09-04 |
Decision Date | 1987-01-15 |