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FDA 510(k)

J & J I-330 SERIES PHYSIOLOGICAL MONITORING & BIOFEEDBACK INSTUMENT AND USE SOFTWARE APPLICATIONS

K-Number: K945826 · 1995-08-04

ApplicantMedical Device Inspection Co., Inc.
Decision Date1995-08-04
Product CodeHCC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

J & J I-330 SERIES PHYSIOLOGICAL MONITORING & BIOFEEDBACK INSTUMENT AND USE SOFTWARE APPLICATIONS is the device name listed in this FDA 510(k) record. The listed applicant is Medical Device Inspection Co., Inc.. It received FDA 510(k) clearance on 1995-08-04 under 510(k) number K945826. The device is classified under product code HCC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the J & J I-330 SERIES PHYSIOLOGICAL MONITORING & BIOFEEDBACK INSTUMENT AND USE SOFTWARE APPLICATIONS?

J & J I-330 SERIES PHYSIOLOGICAL MONITORING & BIOFEEDBACK INSTUMENT AND USE SOFTWARE APPLICATIONS is a medical device that received FDA 510(k) clearance on 1995-08-04. The listed applicant is Medical Device Inspection Co., Inc.. The 510(k) number is K945826.

When did J & J I-330 SERIES PHYSIOLOGICAL MONITORING & BIOFEEDBACK INSTUMENT AND USE SOFTWARE APPLICATIONS receive FDA 510(k) clearance?

J & J I-330 SERIES PHYSIOLOGICAL MONITORING & BIOFEEDBACK INSTUMENT AND USE SOFTWARE APPLICATIONS received FDA 510(k) clearance on 1995-08-04, under 510(k) number K945826.

Who is the listed applicant for J & J I-330 SERIES PHYSIOLOGICAL MONITORING & BIOFEEDBACK INSTUMENT AND USE SOFTWARE APPLICATIONS?

The FDA 510(k) record lists Medical Device Inspection Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for J & J I-330 SERIES PHYSIOLOGICAL MONITORING & BIOFEEDBACK INSTUMENT AND USE SOFTWARE APPLICATIONS?

The FDA product code for J & J I-330 SERIES PHYSIOLOGICAL MONITORING & BIOFEEDBACK INSTUMENT AND USE SOFTWARE APPLICATIONS is HCC.

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Related Devices (Code: HCC)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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