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FDA 510(k)

ULTRABUR

K-Number: K974174 · 1998-03-10

ApplicantMednet Locator, Inc.
Decision Date1998-03-10
Product CodeERL
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ULTRABUR is the device name listed in this FDA 510(k) record. The listed applicant is Mednet Locator, Inc.. It received FDA 510(k) clearance on 1998-03-10 under 510(k) number K974174. The device is classified under product code ERL. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRABUR?

ULTRABUR is a medical device that received FDA 510(k) clearance on 1998-03-10. The listed applicant is Mednet Locator, Inc.. The 510(k) number is K974174.

When did ULTRABUR receive FDA 510(k) clearance?

ULTRABUR received FDA 510(k) clearance on 1998-03-10, under 510(k) number K974174.

Who is the listed applicant for ULTRABUR?

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

What is the FDA product code for ULTRABUR?

The FDA product code for ULTRABUR is ERL.

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Other records listing Mednet Locator, Inc. as applicant

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Related Devices (Code: ERL)

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

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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