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FDA 510(k)

MONITOR LINE W/FILTER & NEEDLE

K-Number: K760994 · 1977-01-06

ApplicantDravon Medical, Inc.
Decision Date1977-01-06
Product CodeKOC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MONITOR LINE W/FILTER & NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Dravon Medical, Inc.. It received FDA 510(k) clearance on 1977-01-06 under 510(k) number K760994. The device is classified under product code KOC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MONITOR LINE W/FILTER & NEEDLE?

MONITOR LINE W/FILTER & NEEDLE is a medical device that received FDA 510(k) clearance on 1977-01-06. The listed applicant is Dravon Medical, Inc.. The 510(k) number is K760994.

When did MONITOR LINE W/FILTER & NEEDLE receive FDA 510(k) clearance?

MONITOR LINE W/FILTER & NEEDLE received FDA 510(k) clearance on 1977-01-06, under 510(k) number K760994.

Who is the listed applicant for MONITOR LINE W/FILTER & NEEDLE?

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

What is the FDA product code for MONITOR LINE W/FILTER & NEEDLE?

The FDA product code for MONITOR LINE W/FILTER & NEEDLE is KOC.

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Other records listing Dravon Medical, 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.

K873455S3086 ARTERIAL, S3087 VENOUS NEONATAL HEMODIALYSISK860770AM-100 I/A AMPACK832739STEDIFLO INFUSION SETK831842DRAVON T CLAMPK812771PERITONEAL DIALYSIS DRAINAGEK812772PERITONEAL DIALYSIS CYCLER SET (8UNIT)

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Related Devices (Code: KOC)

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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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