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FDA 510(k)

CMI VELVET TOUCH VACUUM EXTRACTOR

K-Number: K942725 · 1995-05-05

ApplicantColumbia Medical & Surgical, Inc.
Decision Date1995-05-05
Product CodeHDB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

CMI VELVET TOUCH VACUUM EXTRACTOR is the device name listed in this FDA 510(k) record. The listed applicant is Columbia Medical & Surgical, Inc.. It received FDA 510(k) clearance on 1995-05-05 under 510(k) number K942725. The device is classified under product code HDB. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CMI VELVET TOUCH VACUUM EXTRACTOR?

CMI VELVET TOUCH VACUUM EXTRACTOR is a medical device that received FDA 510(k) clearance on 1995-05-05. The listed applicant is Columbia Medical & Surgical, Inc.. The 510(k) number is K942725.

When did CMI VELVET TOUCH VACUUM EXTRACTOR receive FDA 510(k) clearance?

CMI VELVET TOUCH VACUUM EXTRACTOR received FDA 510(k) clearance on 1995-05-05, under 510(k) number K942725.

Who is the listed applicant for CMI VELVET TOUCH VACUUM EXTRACTOR?

The FDA 510(k) record lists Columbia Medical & Surgical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CMI VELVET TOUCH VACUUM EXTRACTOR?

The FDA product code for CMI VELVET TOUCH VACUUM EXTRACTOR is HDB.

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 Columbia Medical & Surgical, 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.

K932128CMI E-Z FLO BULB P.N. 701K914552CMI VACUUM PUMPK915763MODIFIED DISPOSABLE FETAL VACUUM

Related Devices (Code: HDB)

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.

K250298Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M); Kiwi® Complete Vacuum Delivery System, OmniCup® with Traction Force Indicator (VAC-DUAL MT); Kiwi® Complete Vacuum Delivery System, OmniC Cup® for Cesarean Section (VAC-DUAL C); Kiwi® Complete Vacuum Delivery System, ProCup® (VAC-DUAL S)Clinical Innovations, LLCK041579MEDELA SINGLE USE SILC CUP, MODEL 077.0791Medela AGK043614VACULINK, MODEL VCL 3000Medevco, Inc.K021193FORTUNE SILICONE VACUUM SUCTION, MODEL #1300Fortune Medical Instrument Corp.K020447MITYVAC MERLIN, MODEL 10027Prism Enterprises, Inc.K013460SWIFT LOW PROFILE CUP (PRO CUP)Swift Delivery Products

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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