The following data is part of a premarket notification filed by Eare Consulting Service with the FDA for Vsa 3000 Vibratoryn Sensory Analyzer.
| Device ID | K970180 |
| 510k Number | K970180 |
| Device Name: | VSA 3000 VIBRATORYN SENSORY ANALYZER |
| Classification | Device, Vibration Threshold Measurement |
| Applicant | EARE CONSULTING SERVICE P.O. BOX 1309 Eilat, IL 88112 |
| Contact | Emanuel A Rosen, M.s., R.ph. |
| Correspondent | Emanuel A Rosen, M.s., R.ph. EARE CONSULTING SERVICE P.O. BOX 1309 Eilat, IL 88112 |
| Product Code | LLN |
| CFR Regulation Number | 882.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-17 |
| Decision Date | 1997-04-25 |
| Summary: | summary |