The following data is part of a premarket notification filed by Parker Laboratories, Inc. with the FDA for Eclipse Probe Cover.
| Device ID | K953673 |
| 510k Number | K953673 |
| Device Name: | ECLIPSE PROBE COVER |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | PARKER LABORATORIES, INC. 307 WASHINGTON ST. Orange, NJ 07050 |
| Contact | Susan D Goldstein-falk |
| Correspondent | Susan D Goldstein-falk PARKER LABORATORIES, INC. 307 WASHINGTON ST. Orange, NJ 07050 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-07 |
| Decision Date | 1996-03-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00855683006869 | K953673 | 000 |