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FDA 510(k)

ENTERPRISE

K-Number: K935998 · 1995-11-17

Decision Date1995-11-17
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ENTERPRISE is the device name listed in this FDA 510(k) record. The listed applicant is Camp Intl., Inc.. It received FDA 510(k) clearance on 1995-11-17 under 510(k) number K935998. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENTERPRISE?

ENTERPRISE is a medical device that received FDA 510(k) clearance on 1995-11-17. The listed applicant is Camp Intl., Inc.. The 510(k) number is K935998.

When did ENTERPRISE receive FDA 510(k) clearance?

ENTERPRISE received FDA 510(k) clearance on 1995-11-17, under 510(k) number K935998.

Who is the listed applicant for ENTERPRISE?

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

What is the FDA product code for ENTERPRISE?

The FDA product code for ENTERPRISE is DQX.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Other records listing Camp Intl., Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: DQX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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

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