The following data is part of a premarket notification filed by Helps Products, Inc. with the FDA for Blood Ph Capillary Tubes, Heparin.
Device ID | K881188 |
510k Number | K881188 |
Device Name: | BLOOD PH CAPILLARY TUBES, HEPARIN |
Classification | Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph |
Applicant | HELPS PRODUCTS, INC. 4469 S.W.35TH.STREET Orlando, FL 32811 |
Contact | Brian Lemay |
Correspondent | Brian Lemay HELPS PRODUCTS, INC. 4469 S.W.35TH.STREET Orlando, FL 32811 |
Product Code | CHL |
CFR Regulation Number | 862.1120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-03-21 |
Decision Date | 1988-07-08 |