FDA 510(k)

EXTERNAL JET SYNCHRONIZER, MODEL AMS-1010

K-Number: K883865 · 1989-06-08

Decision Date1989-06-08

Product CodeCBK

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

EXTERNAL JET SYNCHRONIZER, MODEL AMS-1010 is the device name listed in this FDA 510(k) record. The listed applicant is Acutronic Medical Systems AG. It received FDA 510(k) clearance on 1989-06-08 under 510(k) number K883865. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXTERNAL JET SYNCHRONIZER, MODEL AMS-1010?

EXTERNAL JET SYNCHRONIZER, MODEL AMS-1010 is a medical device that received FDA 510(k) clearance on 1989-06-08. The listed applicant is Acutronic Medical Systems AG. The 510(k) number is K883865.

When did EXTERNAL JET SYNCHRONIZER, MODEL AMS-1010 receive FDA 510(k) clearance?

EXTERNAL JET SYNCHRONIZER, MODEL AMS-1010 received FDA 510(k) clearance on 1989-06-08, under 510(k) number K883865.

Who is the listed applicant for EXTERNAL JET SYNCHRONIZER, MODEL AMS-1010?

The FDA 510(k) record lists Acutronic Medical Systems AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EXTERNAL JET SYNCHRONIZER, MODEL AMS-1010?

The FDA product code for EXTERNAL JET SYNCHRONIZER, MODEL AMS-1010 is CBK.

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 Acutronic Medical Systems AG as applicant

K012691MONSOON CRITICAL CARE JET VENTILATOR AND ACCESSORIES K012693MISTRAL CRITICAL CARE JET VENTILATOR AND ACCESSORIES K936009AMS 3000M K900745VS-200S JET VENTILATOR K900744AMS 3000 PORTABLE JET VENTILATOR K863155UNIVERSAL JET VENTILATOR MODEL AMS-1000

View all 12 devices →

Related Devices (Code: CBK)

K253647Evita (V800); Evita (V600)Draegerwerk AG & CO Kgaa K252663Inbentus VersatileIconic Solutions by Murcia, SL K251888VPAP Pediatric Face MaskHsiner Co., Ltd.K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.K252173F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size A (ONIV117A); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size B (ONIV117B); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size C (ONIV117C); F&P OptiNIV ONIV117-F Hospital Vented Full Face Mask with optional Expiratory Filter Compatible with Single-limb Circuits - Size A (ONIV117A-F); F&P OptiNIV ONIV117-F Hospital Vented FullFisher & Paykel Healthcare, Ltd.K243767SV600, SV800 VentilatorShenzhen Mindray Bio-Medical Electronics Co., Ltd.

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.