The following data is part of a premarket notification filed by Pentax Precision Instrument Corp. with the FDA for Ap-4000, Air Pulse Sensory Stimulator.
| Device ID | K964815 |
| 510k Number | K964815 |
| Device Name: | AP-4000, AIR PULSE SENSORY STIMULATOR |
| Classification | Device, Vibration Threshold Measurement |
| Applicant | PENTAX PRECISION INSTRUMENT CORP. 3117 COMMERCE PKWY. Miramar, FL 33025 |
| Contact | Paul Silva |
| Correspondent | Paul Silva PENTAX PRECISION INSTRUMENT CORP. 3117 COMMERCE PKWY. Miramar, FL 33025 |
| Product Code | LLN |
| CFR Regulation Number | 882.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-29 |
| Decision Date | 1997-09-04 |
| Summary: | summary |