Submission Details
| 510(k) Number | K122610 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 27, 2012 |
| Decision Date | August 05, 2013 |
| Days to Decision | 343 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
Cleared
Traditional
PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIES
Aug 2013
Decision
343d
Days
Class 2
Risk
About This 510(k) Submission
K122610 is an FDA 510(k) clearance for the PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIES, a Attachment, Breathing, Positive End Expiratory Pressure (Class II — Special Controls, product code BYE), submitted by Sen MU Technology Co., Ltd. (Kaohsiung City, TW). The FDA issued a Cleared decision on August 5, 2013, 343 days after receiving the submission on August 27, 2012. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5965.
Device Classification
| Product Code | BYE — Attachment, Breathing, Positive End Expiratory Pressure |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 868.5965 |
Manufacturer
Similar Devices — BYE Attachment, Breathing, Positive End Expiratory Pressure
All 79
K160112 · Besmed Health Business Corp
· Apr 2016
K133957 · Galemed Corp.
· Apr 2014
K133210 · S & T Medical Technologies, Inc.
· Mar 2014
K112546 · O-Two Medical Technologies, Inc.
· Dec 2011
K110713 · Airways Development, LLC
· Sep 2011
K103833 · Neoforce Group, Inc.
· Apr 2011