J & J I-330 Series Physiological Monitoring & Biofeedback Instument and Use Software Applications
FDA 510(k) K945826 · Medical Device Inspection Co., Inc.
510(k) numberK945826
Submission
- Device name
- J & J I-330 Series Physiological Monitoring & Biofeedback Instument and Use Software Applications
- Applicant
- Medical Device Inspection Co., Inc.
Great Neck, NY, US - Received
- November 29, 1994
- Decision date
- August 4, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was J & J I-330 Series Physiological Monitoring & Biofeedback Instument and Use Software Applications cleared by the FDA?
J & J I-330 Series Physiological Monitoring & Biofeedback Instument and Use Software Applications (K945826) received a 510(k) decision of Substantially Equivalent on August 4, 1995, 248 days after the submission was received.
What is the product code of K945826?
The FDA product code is HCC – Device, Biofeedback, a Class II (moderate risk) device regulated under 21 CFR 882.5050.