K964815 is an FDA 510(k) clearance for the AP-4000, AIR PULSE SENSORY STIMULATOR. This device is classified as a Device, Vibration Threshold Measurement (Class I - General Controls, product code LLN).
Submitted by Pentax Precision Instrument Corp. (Miramar, US). The FDA issued a Cleared decision on September 4, 1997, 279 days after receiving the submission on November 29, 1996.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1200.
| 510(k) Number | K964815 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 29, 1996 |
| Decision Date | September 04, 1997 |
| Days to Decision | 279 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | LLN — Device, Vibration Threshold Measurement |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 882.1200 |