The following data is part of a premarket notification filed by Somnetics International, Inc. with the FDA for Transcend Auto.
| Device ID | K132127 |
| 510k Number | K132127 |
| Device Name: | TRANSCEND AUTO |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | SOMNETICS INTERNATIONAL, INC. 33 5TH AVE NW, STE 500 New Brighton, MN 55112 |
| Contact | Melinda Swanson |
| Correspondent | Melinda Swanson SOMNETICS INTERNATIONAL, INC. 33 5TH AVE NW, STE 500 New Brighton, MN 55112 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-10 |
| Decision Date | 2013-10-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M9505031090 | K132127 | 000 |
| M9505050170 | K132127 | 000 |
| M9505030230 | K132127 | 000 |
| M9505030260 | K132127 | 000 |
| M9505030840 | K132127 | 000 |
| M9505030290 | K132127 | 000 |
| M9505031040 | K132127 | 000 |
| M9505031050 | K132127 | 000 |
| M9505031060 | K132127 | 000 |
| M9505031070 | K132127 | 000 |
| M9505050010 | K132127 | 000 |