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FDA 510(k)

MONOMER EVACUATION SYSTEM

K-Number: K780202 · 1978-02-21

ApplicantMedishield, Inc.
Decision Date1978-02-21
Product CodeJDY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MONOMER EVACUATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medishield, Inc.. It received FDA 510(k) clearance on 1978-02-21 under 510(k) number K780202. The device is classified under product code JDY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MONOMER EVACUATION SYSTEM?

MONOMER EVACUATION SYSTEM is a medical device that received FDA 510(k) clearance on 1978-02-21. The listed applicant is Medishield, Inc.. The 510(k) number is K780202.

When did MONOMER EVACUATION SYSTEM receive FDA 510(k) clearance?

MONOMER EVACUATION SYSTEM received FDA 510(k) clearance on 1978-02-21, under 510(k) number K780202.

Who is the listed applicant for MONOMER EVACUATION SYSTEM?

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

What is the FDA product code for MONOMER EVACUATION SYSTEM?

The FDA product code for MONOMER EVACUATION SYSTEM is JDY.

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Other records listing Medishield, 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.

K781103SPECTRASCANK780645HMD-2000 BATTERY-POWERED MINI-DRILL, THEK780646AIR-PWOERED COLDRILLK770161MICROFENESTRATED HIP REPLACEMENT COMPON.K761021ANKLE INSTRUMENTS (FREEMAN-SWANSON)K761020ANKLE (FREEMAN-SWANSON)

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Related Devices (Code: JDY)

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.

K902167CONTAIN(TM) LASER PLUME FILTERArbor Technologies, Inc.K902056LASER TRAP 100 LASER PLUME SMOKE EVACUATION FILTERHollister, Inc.K862509CHARCOAL LASER SMOKE FILTER CATALOG NO. 901103-000Lifestream Int'L, Inc.K810542CEMENT FUME EVACUATOR TANK & FILTERWalgen Medical InnoventionsK790877BIOVAC: LFA LASER FUME (SMOKE) EVACUATIOStackhouse Assoc.K770690MASK, VAPOR, MONOMERHowmedica Corp.

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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