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FDA 510(k)

MISTASSIST

K-Number: K942789 · 1994-08-12

ApplicantThe Merlin Corp.
Decision Date1994-08-12
Product CodeLRD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MISTASSIST is the device name listed in this FDA 510(k) record. The listed applicant is The Merlin Corp.. It received FDA 510(k) clearance on 1994-08-12 under 510(k) number K942789. The device is classified under product code LRD. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MISTASSIST?

MISTASSIST is a medical device that received FDA 510(k) clearance on 1994-08-12. The listed applicant is The Merlin Corp.. The 510(k) number is K942789.

When did MISTASSIST receive FDA 510(k) clearance?

MISTASSIST received FDA 510(k) clearance on 1994-08-12, under 510(k) number K942789.

Who is the listed applicant for MISTASSIST?

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

What is the FDA product code for MISTASSIST?

The FDA product code for MISTASSIST is LRD.

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.

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Other records listing The Merlin Corp. 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.

K953055MISTASSIST BREATHING EXERCISER

Related Devices (Code: LRD)

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.

K984345AROMAPATCHEnvis, Inc.K932522AMSCO STERILE RECOVERIES SURGICAL PACKSAmsco Sterile Recoveries, Inc.K940133THE EXPANDACELL EAR PACKDenver Splint Co.K925022SURGICAL TRAY (STERILE)Customed, Inc.K920842AEROSOL DELIVERY SYSTEMSHospitak, Inc.

Official Source

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

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