K883825 is an FDA 510(k) clearance for the MODIFIED SANDERS BI-PAPEASY. This device is classified as a Attachment, Breathing, Positive End Expiratory Pressure (Class II - Special Controls, product code BYE).
Submitted by Respironics, Inc. (Murrysville, US). The FDA issued a Cleared decision on December 8, 1988, 90 days after receiving the submission on September 9, 1988.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5965.
| 510(k) Number | K883825 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 09, 1988 |
| Decision Date | December 08, 1988 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | BYE — Attachment, Breathing, Positive End Expiratory Pressure |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5965 |