The following data is part of a premarket notification filed by Interspec, Inc. with the FDA for Interspec 2 Mhz, Transcranial Pulsed Wave Doppler.
| Device ID | K900155 |
| 510k Number | K900155 |
| Device Name: | INTERSPEC 2 MHZ, TRANSCRANIAL PULSED WAVE DOPPLER |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | INTERSPEC, INC. 110 WEST BUTLER AVE. Ambler, PA 19002 |
| Contact | Arthur J Schenck |
| Correspondent | Arthur J Schenck INTERSPEC, INC. 110 WEST BUTLER AVE. Ambler, PA 19002 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-12 |
| Decision Date | 1990-10-05 |