FDA 510(k)

ACMI ASPIRATOR KIT #8808

K-Number: K811218 · 1981-07-01

ApplicantAmerican Cystocope Makers, Inc.

Decision Date1981-07-01

Product CodeEOQ

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

ACMI ASPIRATOR KIT #8808 is the device name listed in this FDA 510(k) record. The listed applicant is American Cystocope Makers, Inc.. It received FDA 510(k) clearance on 1981-07-01 under 510(k) number K811218. The device is classified under product code EOQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACMI ASPIRATOR KIT #8808?

ACMI ASPIRATOR KIT #8808 is a medical device that received FDA 510(k) clearance on 1981-07-01. The listed applicant is American Cystocope Makers, Inc.. The 510(k) number is K811218.

When did ACMI ASPIRATOR KIT #8808 receive FDA 510(k) clearance?

ACMI ASPIRATOR KIT #8808 received FDA 510(k) clearance on 1981-07-01, under 510(k) number K811218.

Who is the listed applicant for ACMI ASPIRATOR KIT #8808?

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

What is the FDA product code for ACMI ASPIRATOR KIT #8808?

The FDA product code for ACMI ASPIRATOR KIT #8808 is EOQ.

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing American Cystocope Makers, Inc. as applicant

K832040STERILE FLUID PRODUCING UNIT #EP550 K812637ACMI BIPOLAR HEMOSTATIC SOURCE K803214ACMI BIPOLAR HEMOSTATIC ELECTRODE K791182ACMI RIGI-FLEX NEPHORSCOPE K770754DUODENOSCOPE, MOLEL TX-6 K760822MODEL TX-8 PANENDOSCOPE

View all 9 devices →

Related Devices (Code: EOQ)

K261637Single-use Flexible BronchoscopeHunan Vathin Medical Instrument Co., Ltd.K260309Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler SetAmbu A/S K2540263.8mm Slim ProVu Video Bronchoscope (090-02-0038U); 5.0mm Regular ProVu Video Bronchoscope (090-02-0050U); 6.0mm Large ProVu Video Bronchoscope (090-02-0060U); ProVu Video Bronchoscope 8 display (040-07-0082U)Flexicare Medical Limited.K260382MONARCH™ Platform (MON-000008)Auris Health, Inc.K254037LungFlow Airway CatheterFree Flow Medical, Inc.K253137FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840TFujifilm Corporation

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.