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FDA 510(k)

CMI VACUUM DELIVERY SYSTEM #003C AND #004C

K-Number: K881306 · 1988-06-13

ApplicantChallenge Mfg., Inc.
Decision Date1988-06-13
Product CodeHDB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

CMI VACUUM DELIVERY SYSTEM #003C AND #004C is the device name listed in this FDA 510(k) record. The listed applicant is Challenge Mfg., Inc.. It received FDA 510(k) clearance on 1988-06-13 under 510(k) number K881306. 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 VACUUM DELIVERY SYSTEM #003C AND #004C?

CMI VACUUM DELIVERY SYSTEM #003C AND #004C is a medical device that received FDA 510(k) clearance on 1988-06-13. The listed applicant is Challenge Mfg., Inc.. The 510(k) number is K881306.

When did CMI VACUUM DELIVERY SYSTEM #003C AND #004C receive FDA 510(k) clearance?

CMI VACUUM DELIVERY SYSTEM #003C AND #004C received FDA 510(k) clearance on 1988-06-13, under 510(k) number K881306.

Who is the listed applicant for CMI VACUUM DELIVERY SYSTEM #003C AND #004C?

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

What is the FDA product code for CMI VACUUM DELIVERY SYSTEM #003C AND #004C?

The FDA product code for CMI VACUUM DELIVERY SYSTEM #003C AND #004C 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 Challenge Mfg., 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.

K910788CMI TENDER TOUCH VE #303TT AND 404TTK895446CMI VACUUM PUMP W/#101A VACUUM PUMP (AUTO-CLAVE.)K881967CMI VACUUM PUMP #001C - VACUUM PUMP (NON-ELECTRI.)

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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