The following data is part of a premarket notification filed by Cheen Houng Ent. Co. Ltd. with the FDA for Y2000 Pocket Rescue.
| Device ID | K010191 |
| 510k Number | K010191 |
| Device Name: | Y2000 POCKET RESCUE |
| Classification | Valve, Non-rebreathing |
| Applicant | CHEEN HOUNG ENT. CO. LTD. 23 SAN DREEN ST., ALLEY 11, LANE 65 Taipei (shulin), TW 23805 |
| Contact | Jay Wang |
| Correspondent | Jay Wang CHEEN HOUNG ENT. CO. LTD. 23 SAN DREEN ST., ALLEY 11, LANE 65 Taipei (shulin), TW 23805 |
| Product Code | CBP |
| CFR Regulation Number | 868.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-01-22 |
| Decision Date | 2001-03-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00260720012107 | K010191 | 000 |
| B0022025HS0 | K010191 | 000 |
| B0022000CC0 | K010191 | 000 |
| B00220000 | K010191 | 000 |
| B002000CC0 | K010191 | 000 |
| 00026072011430 | K010191 | 000 |
| 00026072012109 | K010191 | 000 |
| 00026072011522 | K010191 | 000 |
| 00026072011515 | K010191 | 000 |
| 00026072011508 | K010191 | 000 |
| 00026072011492 | K010191 | 000 |
| 00026072011478 | K010191 | 000 |
| 00026072011461 | K010191 | 000 |
| 00026072011454 | K010191 | 000 |
| 00026072011447 | K010191 | 000 |
| 00026072022993 | K010191 | 000 |
| 20888277728988 | K010191 | 000 |
| B0022025HSCC0 | K010191 | 000 |
| B0022025HSCCX0 | K010191 | 000 |
| B00220300 | K010191 | 000 |
| 00260720011520 | K010191 | 000 |
| 00260720011513 | K010191 | 000 |
| 00260720011506 | K010191 | 000 |
| 00260720011490 | K010191 | 000 |
| 00260720011483 | K010191 | 000 |
| 00260720011476 | K010191 | 000 |
| 00260720011469 | K010191 | 000 |
| 00260720011452 | K010191 | 000 |
| 00260720011445 | K010191 | 000 |
| 00260720011438 | K010191 | 000 |
| B188LIFE1020 | K010191 | 000 |
| B188LIFE100B0 | K010191 | 000 |
| B188LIFE1000 | K010191 | 000 |
| B0023000P5 | K010191 | 000 |
| B00230007 | K010191 | 000 |
| B0022030P2 | K010191 | 000 |
| B0023000X7 | K010191 | 000 |