The following data is part of a premarket notification filed by Sheathing Technologies, Inc. with the FDA for Sheathes Ultrasound Probe Covers.
| Device ID | K153212 |
| 510k Number | K153212 |
| Device Name: | Sheathes Ultrasound Probe Covers |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | Sheathing Technologies, Inc. 18431 TECHNOLOGY DRIVE Morgan Hill, CA 95037 |
| Contact | Jennifer Downing |
| Correspondent | Jennifer Downing SHEATING TECHNOLOGIES, INC 18431 TECHNOLOGY DRIVE Morgan Hill, CA 95037 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-05 |
| Decision Date | 2016-03-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20842418104475 | K153212 | 000 |
| 20842418104697 | K153212 | 000 |
| 20842418104703 | K153212 | 000 |
| 20842418104673 | K153212 | 000 |
| 20842418100903 | K153212 | 000 |
| 20842418100934 | K153212 | 000 |
| 20842418100989 | K153212 | 000 |
| 10842418102115 | K153212 | 000 |
| 10842418102160 | K153212 | 000 |
| 20842418102259 | K153212 | 000 |
| 20842418102280 | K153212 | 000 |
| 20842418102297 | K153212 | 000 |
| 20842418102303 | K153212 | 000 |
| 20842418102310 | K153212 | 000 |
| 20842418104666 | K153212 | 000 |