K970688 is an FDA 510(k) clearance for the POCKET RESCUE. This device is classified as a Mask, Oxygen, Non-rebreathing (Class I - General Controls, product code KGB).
Submitted by Cheen Houng Ent. Co. , Ltd. (Taipei (Shulin), TW). The FDA issued a Cleared decision on September 26, 1997, 213 days after receiving the submission on February 25, 1997.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5570.
| 510(k) Number | K970688 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 25, 1997 |
| Decision Date | September 26, 1997 |
| Days to Decision | 213 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | KGB — Mask, Oxygen, Non-rebreathing |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 868.5570 |