The following data is part of a premarket notification filed by Redline Products (pty) Ltd. with the FDA for Redline Alcohol Breath Tester.
| Device ID | K072953 |
| 510k Number | K072953 |
| Device Name: | REDLINE ALCOHOL BREATH TESTER |
| Classification | Devices, Breath Trapping, Alcohol |
| Applicant | REDLINE PRODUCTS (PTY) LTD. 10 CROMPTON ROAD Strand Industria, Western Cape, ZA 7140 |
| Contact | Hugh A Butler |
| Correspondent | Hugh A Butler REDLINE PRODUCTS (PTY) LTD. 10 CROMPTON ROAD Strand Industria, Western Cape, ZA 7140 |
| Product Code | DJZ |
| CFR Regulation Number | 862.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-10-18 |
| Decision Date | 2008-01-07 |