Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

VIPERCAM

K-Number: K981534 · 1998-07-23

Decision Date1998-07-23
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

VIPERCAM is the device name listed in this FDA 510(k) record. The listed applicant is Integra Medical. It received FDA 510(k) clearance on 1998-07-23 under 510(k) number K981534. The device is classified under product code EIA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIPERCAM?

VIPERCAM is a medical device that received FDA 510(k) clearance on 1998-07-23. The listed applicant is Integra Medical. The 510(k) number is K981534.

When did VIPERCAM receive FDA 510(k) clearance?

VIPERCAM received FDA 510(k) clearance on 1998-07-23, under 510(k) number K981534.

Who is the listed applicant for VIPERCAM?

The FDA 510(k) record lists Integra Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VIPERCAM?

The FDA product code for VIPERCAM is EIA.

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 Integra Medical 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: EIA)

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

View on FDA Database →

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

↑