AP-4000, Air Pulse Sensory Stimulator
FDA 510(k) K964815 · Pentax Precision Instrument Corp.
510(k) numberK964815
Submission
- Device name
- AP-4000, Air Pulse Sensory Stimulator
- Applicant
- Pentax Precision Instrument Corp.
Miramar, FL, US - Received
- November 29, 1996
- Decision date
- September 4, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was AP-4000, Air Pulse Sensory Stimulator cleared by the FDA?
AP-4000, Air Pulse Sensory Stimulator (K964815) received a 510(k) decision of Substantially Equivalent on September 4, 1997, 279 days after the submission was received.
What is the product code of K964815?
The FDA product code is LLN – Device, Vibration Threshold Measurement, a Class I (low risk) device regulated under 21 CFR 882.1200.