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FDA 510(k)

CMI VACUUM PUMP W/#101A VACUUM PUMP (AUTO-CLAVE.)

K-Number: K895446 · 1989-11-27

ApplicantChallenge Mfg., Inc.
Decision Date1989-11-27
Product CodeHDB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

CMI VACUUM PUMP W/#101A VACUUM PUMP (AUTO-CLAVE.) 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 1989-11-27 under 510(k) number K895446. 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 PUMP W/#101A VACUUM PUMP (AUTO-CLAVE.)?

CMI VACUUM PUMP W/#101A VACUUM PUMP (AUTO-CLAVE.) is a medical device that received FDA 510(k) clearance on 1989-11-27. The listed applicant is Challenge Mfg., Inc.. The 510(k) number is K895446.

When did CMI VACUUM PUMP W/#101A VACUUM PUMP (AUTO-CLAVE.) receive FDA 510(k) clearance?

CMI VACUUM PUMP W/#101A VACUUM PUMP (AUTO-CLAVE.) received FDA 510(k) clearance on 1989-11-27, under 510(k) number K895446.

Who is the listed applicant for CMI VACUUM PUMP W/#101A VACUUM PUMP (AUTO-CLAVE.)?

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 PUMP W/#101A VACUUM PUMP (AUTO-CLAVE.)?

The FDA product code for CMI VACUUM PUMP W/#101A VACUUM PUMP (AUTO-CLAVE.) 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 404TTK881306CMI VACUUM DELIVERY SYSTEM #003C AND #004CK881967CMI 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

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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