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FDA 510(k)

EMBLA

K-Number: K971813 · 1998-01-16

ApplicantFerguson Medical
Decision Date1998-01-16
Product CodeOLV
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

EMBLA is the device name listed in this FDA 510(k) record. The listed applicant is Ferguson Medical. It received FDA 510(k) clearance on 1998-01-16 under 510(k) number K971813. The device is classified under product code OLV. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMBLA?

EMBLA is a medical device that received FDA 510(k) clearance on 1998-01-16. The listed applicant is Ferguson Medical. The 510(k) number is K971813.

When did EMBLA receive FDA 510(k) clearance?

EMBLA received FDA 510(k) clearance on 1998-01-16, under 510(k) number K971813.

Who is the listed applicant for EMBLA?

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

What is the FDA product code for EMBLA?

The FDA product code for EMBLA is OLV.

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Other records listing Ferguson Medical 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.

K033153DICOM THEATERK963794PUNCTURENEEDLEK962615TUMORLOCALIZER MRIK972217ORTHOPEDIC SCREW SYSTEMK972219ORTHOPEDIC PLATE SYSTEMK970819TARGOBEAM

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Related Devices (Code: OLV)

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.

K261747Report StudioBeacon Biosignals, Inc.K260585Noxturnal WebNox Medical EhfK242447Falcon HSTCompumedics LimitedK241288Noxturnal WebNox Medical EhfK240700HomeSleepTest (HST, HST REM+)Somnomedics GmbHK213007Cerebra Sleep SystemCerebra Medical , Ltd.

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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