The following data is part of a premarket notification filed by Safersonic Medizinprodukte Gmbh with the FDA for Safersonic Sonography Cover.
| Device ID | K092858 |
| 510k Number | K092858 |
| Device Name: | SAFERSONIC SONOGRAPHY COVER |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | SAFERSONIC MEDIZINPRODUKTE GMBH 5401 S. COTTONWOOD CT. Greenwood Village, CO 80121 |
| Contact | Kevin Walls |
| Correspondent | Kevin Walls SAFERSONIC MEDIZINPRODUKTE GMBH 5401 S. COTTONWOOD CT. Greenwood Village, CO 80121 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-16 |
| Decision Date | 2009-11-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B748AR350050DUS0 | K092858 | 000 |
| B748AR350050DEU0 | K092858 | 000 |