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FDA 510(k)

BIOMEDICAL HORIZONS MODEL 1001

K-Number: K921369 · 1992-05-11

ApplicantBiomedical Horizons, Inc.
Decision Date1992-05-11
Product CodeKNN
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

BIOMEDICAL HORIZONS MODEL 1001 is the device name listed in this FDA 510(k) record. The listed applicant is Biomedical Horizons, Inc.. It received FDA 510(k) clearance on 1992-05-11 under 510(k) number K921369. The device is classified under product code KNN. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOMEDICAL HORIZONS MODEL 1001?

BIOMEDICAL HORIZONS MODEL 1001 is a medical device that received FDA 510(k) clearance on 1992-05-11. The listed applicant is Biomedical Horizons, Inc.. The 510(k) number is K921369.

When did BIOMEDICAL HORIZONS MODEL 1001 receive FDA 510(k) clearance?

BIOMEDICAL HORIZONS MODEL 1001 received FDA 510(k) clearance on 1992-05-11, under 510(k) number K921369.

Who is the listed applicant for BIOMEDICAL HORIZONS MODEL 1001?

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

What is the FDA product code for BIOMEDICAL HORIZONS MODEL 1001?

The FDA product code for BIOMEDICAL HORIZONS MODEL 1001 is KNN.

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 Biomedical Horizons, 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.

K971892BIOMEDICAL HORIZONS INC. COMPRESSION PUMP, MODEL 651

Related Devices (Code: KNN)

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.

K211919KISS Dynamic Back Support, KISS Dynamic Solid Drop SeatKinetic Innovative Seating System, LLCK942309DYNASTY U1-31 (GELL/CELL)Foley & LardnerK942311DYNASTY U1-33 AGMFoley & LardnerK942308DYNASTY GC 12400 (GELL/CELL)Foley & LardnerK942310DYNASTY GC 12550 (GELL/CELL)Foley & LardnerK942312ALDEN LINEAGE WHEELCHAIR CUSHIONLewis W. Ward

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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