FDA 510(k)

HCG CONTROLS

K-Number: K970176 · 1997-02-06

ApplicantInternational Newtech Development, Inc.

Decision Date1997-02-06

Product CodeJJX

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

HCG CONTROLS is the device name listed in this FDA 510(k) record. The listed applicant is International Newtech Development, Inc.. It received FDA 510(k) clearance on 1997-02-06 under 510(k) number K970176. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HCG CONTROLS?

HCG CONTROLS is a medical device that received FDA 510(k) clearance on 1997-02-06. The listed applicant is International Newtech Development, Inc.. The 510(k) number is K970176.

When did HCG CONTROLS receive FDA 510(k) clearance?

HCG CONTROLS received FDA 510(k) clearance on 1997-02-06, under 510(k) number K970176.

Who is the listed applicant for HCG CONTROLS?

The FDA 510(k) record lists International Newtech Development, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HCG CONTROLS?

The FDA product code for HCG CONTROLS is JJX.

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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.