The following data is part of a premarket notification filed by Civco Medical Instruments Co., Inc. with the FDA for Astra Tee Transesophageal Probe Reprocessor, Astra Vr Endovaginal/endorectal Probe Reprocessor.
| Device ID | K163313 |
| 510k Number | K163313 |
| Device Name: | ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe Reprocessor |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | CIVCO MEDICAL INSTRUMENTS CO., INC. (D/B/A CIVCO MEDICAL SOLUTIONS) 6 WINTER AVE Deep River, CT 06417 |
| Contact | Kevin Mader |
| Correspondent | Kevin Mader CIVCO MEDICAL INSTRUMENTS CO., INC. (D/B/A CIVCO MEDICAL SOLUTIONS) 6 WINTER AVE Deep River, CT 06417 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-23 |
| Decision Date | 2017-06-09 |
| Summary: | summary |