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FDA 510(k)

STEALTHSHIELD

K-Number: K970755 · 1997-04-15

ApplicantVital Connections, Inc.
Decision Date1997-04-15
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

STEALTHSHIELD is the device name listed in this FDA 510(k) record. The listed applicant is Vital Connections, Inc.. It received FDA 510(k) clearance on 1997-04-15 under 510(k) number K970755. The device is classified under product code DRX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STEALTHSHIELD?

STEALTHSHIELD is a medical device that received FDA 510(k) clearance on 1997-04-15. The listed applicant is Vital Connections, Inc.. The 510(k) number is K970755.

When did STEALTHSHIELD receive FDA 510(k) clearance?

STEALTHSHIELD received FDA 510(k) clearance on 1997-04-15, under 510(k) number K970755.

Who is the listed applicant for STEALTHSHIELD?

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

What is the FDA product code for STEALTHSHIELD?

The FDA product code for STEALTHSHIELD is DRX.

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.

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Other records listing Vital Connections, 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.

K880320ELECTRODE CABLE

Related Devices (Code: DRX)

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.

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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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