The following data is part of a premarket notification filed by Cheen Houng Ent. Co. Ltd. with the FDA for Breath Shake.
| Device ID | K121587 |
| 510k Number | K121587 |
| Device Name: | BREATH SHAKE |
| Classification | Percussor, Powered-electric |
| Applicant | CHEEN HOUNG ENT. CO. LTD. 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden CHEEN HOUNG ENT. CO. LTD. 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 |
| Product Code | BYI |
| CFR Regulation Number | 868.5665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-31 |
| Decision Date | 2013-11-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10641043370025 | K121587 | 000 |