The following data is part of a premarket notification filed by Hf Scientific, Inc. with the FDA for Micro Co2 Apparatus.
Device ID | K880967 |
510k Number | K880967 |
Device Name: | MICRO CO2 APPARATUS |
Classification | Volumetric/manometric, Carbon-dioxide |
Applicant | HF SCIENTIFIC, INC. 3052 METRO PARKWAY SE Ft. Myers, FL 33916 |
Contact | Barbara H Sneade |
Correspondent | Barbara H Sneade HF SCIENTIFIC, INC. 3052 METRO PARKWAY SE Ft. Myers, FL 33916 |
Product Code | CIE |
CFR Regulation Number | 862.1160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-03-08 |
Decision Date | 1988-04-28 |