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FDA 510(k)

DYNAREX UMBILICAL CORD LAMP, MODELS 6833 AND 6833-B

K-Number: K012917 · 2001-11-28

ApplicantDynarex Corp.
Decision Date2001-11-28
Product CodeHFW
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

DYNAREX UMBILICAL CORD LAMP, MODELS 6833 AND 6833-B is the device name listed in this FDA 510(k) record. The listed applicant is Dynarex Corp.. It received FDA 510(k) clearance on 2001-11-28 under 510(k) number K012917. The device is classified under product code HFW. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DYNAREX UMBILICAL CORD LAMP, MODELS 6833 AND 6833-B?

DYNAREX UMBILICAL CORD LAMP, MODELS 6833 AND 6833-B is a medical device that received FDA 510(k) clearance on 2001-11-28. The listed applicant is Dynarex Corp.. The 510(k) number is K012917.

When did DYNAREX UMBILICAL CORD LAMP, MODELS 6833 AND 6833-B receive FDA 510(k) clearance?

DYNAREX UMBILICAL CORD LAMP, MODELS 6833 AND 6833-B received FDA 510(k) clearance on 2001-11-28, under 510(k) number K012917.

Who is the listed applicant for DYNAREX UMBILICAL CORD LAMP, MODELS 6833 AND 6833-B?

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

What is the FDA product code for DYNAREX UMBILICAL CORD LAMP, MODELS 6833 AND 6833-B?

The FDA product code for DYNAREX UMBILICAL CORD LAMP, MODELS 6833 AND 6833-B is HFW.

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Other records listing Dynarex 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.

K052743DYNAREX CPR SHIELD WITH ONE WAY VALVE AND BARRIER FILTER, MODEL 4921K052314DYNAREX VAGINAL SPECULA 4900, MODELS 4911-SMALL, 4912-MEDIUM, 4913-LARGEK012816DYNAREX IODOFORM PACKING STRIPS, MODELS 3411, 3412, 3413, 3414K012957TOWEL DRAPE, MODELS 4409, 4410K991694DYNAREX DRAIN SPONGEK991695DYNAREX NON-WOVEN SPONGE

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Related Devices (Code: HFW)

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.

K041332JOEY CLAMP OPENING TOOLMaternus, Inc.K033846KAEN YIH UMBILICAL CORD CLAMPKaen Yih Enterprise Co., Ltd.K020718SECURLINE UMBILICAL CORD CLAMP #3505 STERILE #3515 NON-STERILEPrecision Dynamics Corp.K021055BUSSE UMBILICAL CORD CLAMP CUTTERBusse Hospital Disposables, Inc.K011621KOALA CLAMP, KOALA CLAMP AND CUTTERMaternus, Inc.K010695KOALA CLAMPMaternus, Inc.

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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