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 |