K981415 is an FDA 510(k) clearance for the 0-20 CM H20 PEEP VALVE. This device is classified as a Attachment, Breathing, Positive End Expiratory Pressure (Class II - Special Controls, product code BYE).
Submitted by Cheen Houng Ent. Co. , Ltd. (Taipei (Shulin), TW). The FDA issued a Cleared decision on July 14, 1998, 85 days after receiving the submission on April 20, 1998.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5965.
| 510(k) Number | K981415 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 20, 1998 |
| Decision Date | July 14, 1998 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BYE — Attachment, Breathing, Positive End Expiratory Pressure |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5965 |