The following data is part of a premarket notification filed by Cheen Houng Ent. Co. Ltd. with the FDA for Pocket Rescue.
| Device ID | K970688 |
| 510k Number | K970688 |
| Device Name: | POCKET RESCUE |
| Classification | Mask, Oxygen, Non-rebreathing |
| Applicant | CHEEN HOUNG ENT. CO. LTD. 23 ALLEY 11 LANE 65 SAN DREEN STREET Taipei (shulin), TW 23805 |
| Contact | Jay Wang |
| Correspondent | Jay Wang CHEEN HOUNG ENT. CO. LTD. 23 ALLEY 11 LANE 65 SAN DREEN STREET Taipei (shulin), TW 23805 |
| Product Code | KGB |
| CFR Regulation Number | 868.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-25 |
| Decision Date | 1997-09-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817643021220 | K970688 | 000 |
| 00817643020346 | K970688 | 000 |
| 00817643020339 | K970688 | 000 |
| 00817643020322 | K970688 | 000 |