The following data is part of a premarket notification filed by Sen Mu Technology Co., Ltd. with the FDA for Plaxtron Cpap System, Model Ch-ffm-87xx/ch-ffm-88xx Series.
| Device ID | K122610 |
| 510k Number | K122610 |
| Device Name: | PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIES |
| Classification | Attachment, Breathing, Positive End Expiratory Pressure |
| Applicant | SEN MU TECHNOLOGY CO., LTD. NO. 15-2, LANE 26, MINCYUAN 1SR RD LINGYA DISTRICT Kaohsiung City, TW 802 |
| Contact | Ming-yie Jn, Ph.d. |
| Correspondent | Ming-yie Jn, Ph.d. SEN MU TECHNOLOGY CO., LTD. NO. 15-2, LANE 26, MINCYUAN 1SR RD LINGYA DISTRICT Kaohsiung City, TW 802 |
| Product Code | BYE |
| CFR Regulation Number | 868.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-27 |
| Decision Date | 2013-08-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B20087101 | K122610 | 000 |
| B0028705NK1 | K122610 | 000 |
| B00287001 | K122610 | 000 |
| B0028700M6 | K122610 | 000 |
| B00287050 | K122610 | 000 |
| B0028705M6 | K122610 | 000 |
| B00287101 | K122610 | 000 |
| B20087501 | K122610 | 000 |
| B00287551 | K122610 | 000 |
| B00288001 | K122610 | 000 |
| B0028800NK0 | K122610 | 000 |
| B00288051 | K122610 | 000 |
| B0028805NK1 | K122610 | 000 |
| B00288101 | K122610 | 000 |
| B0028710M6 | K122610 | 000 |
| B0028810NK1 | K122610 | 000 |
| B00288501 | K122610 | 000 |
| B00288551 | K122610 | 000 |
| B0028700NK1 | K122610 | 000 |