The following data is part of a premarket notification filed by Alcopro, Inc. with the FDA for Alco-breath Tube, Checkpoint Breath Alcohol Test.
| Device ID | K102225 |
| 510k Number | K102225 |
| Device Name: | ALCO-BREATH TUBE, CHECKPOINT BREATH ALCOHOL TEST |
| Classification | Devices, Breath Trapping, Alcohol |
| Applicant | ALCOPRO, INC. 1560 E. EDINGER AVENUE, SUITE B Santa Ana, CA 92705 |
| Contact | Perry Rucker |
| Correspondent | Perry Rucker ALCOPRO, INC. 1560 E. EDINGER AVENUE, SUITE B Santa Ana, CA 92705 |
| Product Code | DJZ |
| CFR Regulation Number | 862.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-09 |
| Decision Date | 2011-04-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| G354CCP084104 | K102225 | 000 |
| G354AAB08400 | K102225 | 000 |
| G354AAB15202 | K102225 | 000 |
| G354AAB15400 | K102225 | 000 |
| G354CCP022001 | K102225 | 000 |
| G354CCP024100 | K102225 | 000 |
| G354CCP042002 | K102225 | 000 |
| G354CCP044104 | K102225 | 000 |
| G354CCP082002 | K102225 | 000 |
| G354AAB08202 | K102225 | 000 |