The following data is part of a premarket notification filed by Starfish Product Engineering Inc. with the FDA for Pod B-scan.
| Device ID | K070884 |
| 510k Number | K070884 |
| Device Name: | POD B-SCAN |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | STARFISH PRODUCT ENGINEERING INC. #5-555 ARDERSIER ROAD Victoria, B.c.,, CA V8z 1c8 |
| Contact | Dayrl Wisdahl |
| Correspondent | Neil E Devine, Jr. INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-03-30 |
| Decision Date | 2007-04-11 |
| Summary: | summary |