FDA 510(k)

EMERGENCY ROOM PACK

K-Number: K850338 · 1985-03-25

Decision Date1985-03-25

Product Code

DecisionSubstantially Equivalent

Device Summary

EMERGENCY ROOM PACK is the device name listed in this FDA 510(k) record. The listed applicant is Marwood Medical, Inc.. It received FDA 510(k) clearance on 1985-03-25 under 510(k) number K850338. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMERGENCY ROOM PACK?

EMERGENCY ROOM PACK is a medical device that received FDA 510(k) clearance on 1985-03-25. The listed applicant is Marwood Medical, Inc.. The 510(k) number is K850338.

When did EMERGENCY ROOM PACK receive FDA 510(k) clearance?

EMERGENCY ROOM PACK received FDA 510(k) clearance on 1985-03-25, under 510(k) number K850338.

Who is the listed applicant for EMERGENCY ROOM PACK?

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

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Other records listing Marwood Medical, Inc. as applicant

K850340EYE PROCEDURE PACK K850339SPECIAL PROCEDURES PACK K850337CARDIAC CATHETERIZATION PACK K850341CARDIOVASCULAR SET UP K840620TPN/CVP DRESSING CHANGE KIT K840619I.V. START KIT

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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.