The following data is part of a premarket notification filed by Rf Design Assoc., Inc. with the FDA for Rf-100 Monitor, Rf-p-2.5, Rf-p-5, Rf-p-7.5 Probes.
| Device ID | K885211 |
| 510k Number | K885211 |
| Device Name: | RF-100 MONITOR, RF-P-2.5, RF-P-5, RF-P-7.5 PROBES |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | RF DESIGN ASSOC., INC. 1224 MONTEREY CIRCLE Plano, TX 75075 |
| Contact | Kenneth Goldstein |
| Correspondent | Kenneth Goldstein RF DESIGN ASSOC., INC. 1224 MONTEREY CIRCLE Plano, TX 75075 |
| Product Code | IYN |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-14 |
| Decision Date | 1989-06-13 |