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FDA 510(k)

BIRTHWELL BIRTHING SYSTEM

K-Number: K831998 · 1983-09-12

ApplicantQulab Co.
Decision Date1983-09-12
Product CodeKNC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

BIRTHWELL BIRTHING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Qulab Co.. It received FDA 510(k) clearance on 1983-09-12 under 510(k) number K831998. The device is classified under product code KNC. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIRTHWELL BIRTHING SYSTEM?

BIRTHWELL BIRTHING SYSTEM is a medical device that received FDA 510(k) clearance on 1983-09-12. The listed applicant is Qulab Co.. The 510(k) number is K831998.

When did BIRTHWELL BIRTHING SYSTEM receive FDA 510(k) clearance?

BIRTHWELL BIRTHING SYSTEM received FDA 510(k) clearance on 1983-09-12, under 510(k) number K831998.

Who is the listed applicant for BIRTHWELL BIRTHING SYSTEM?

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

What is the FDA product code for BIRTHWELL BIRTHING SYSTEM?

The FDA product code for BIRTHWELL BIRTHING SYSTEM is KNC.

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Related Devices (Code: KNC)

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.

K001261L720 EXAMINATION CHAIRLuneau Gynecologie SAK932035NON-LINTING DELIVERY BLANKETAmsco Sterile Recoveries, Inc.K924420MEDICAL DISPOSABLE BEDDINGHill-Rom, Inc.K914544BD6000 THE OPTIMA & BD5000 BIRTHING BEDLic Care, Inc.K915779AFFINITY BED MODEL 3600 SERIESHill-Rom, Inc.K903973GARDOSI BIRTHING CUSHIONGraphic Controls Corp.

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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