Case IV Computer Aided Sensory Evaluator Version 4
FDA 510(k) K910624 · Wr Medical Electronics Co.
510(k) numberK910624
Submission
- Device name
- Case IV Computer Aided Sensory Evaluator Version 4
- Applicant
- Wr Medical Electronics Co.
Stillwater, MN, US - Received
- February 12, 1991
- Decision date
- January 17, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K934368 | NK Pressure-Specified Sensory Device, Model PSSD-001LLN · Traditional | Nk Biotechnical Engineering Co. | 08/11/1994SE |
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Questions and answers
When was Case IV Computer Aided Sensory Evaluator Version 4 cleared by the FDA?
Case IV Computer Aided Sensory Evaluator Version 4 (K910624) received a 510(k) decision of Substantially Equivalent on January 17, 1992, 339 days after the submission was received.
What is the product code of K910624?
The FDA product code is LLN – Device, Vibration Threshold Measurement, a Class I (low risk) device regulated under 21 CFR 882.1200.