Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

BABYLOG 8000 INFANT VENTILATOR

K-Number: K926292 · 1994-04-19

ApplicantDrager, Inc.
Decision Date1994-04-19
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BABYLOG 8000 INFANT VENTILATOR is the device name listed in this FDA 510(k) record. The listed applicant is Drager, Inc.. It received FDA 510(k) clearance on 1994-04-19 under 510(k) number K926292. 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 BABYLOG 8000 INFANT VENTILATOR?

BABYLOG 8000 INFANT VENTILATOR is a medical device that received FDA 510(k) clearance on 1994-04-19. The listed applicant is Drager, Inc.. The 510(k) number is K926292.

When did BABYLOG 8000 INFANT VENTILATOR receive FDA 510(k) clearance?

BABYLOG 8000 INFANT VENTILATOR received FDA 510(k) clearance on 1994-04-19, under 510(k) number K926292.

Who is the listed applicant for BABYLOG 8000 INFANT VENTILATOR?

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

What is the FDA product code for BABYLOG 8000 INFANT VENTILATOR?

The FDA product code for BABYLOG 8000 INFANT VENTILATOR 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_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 Drager, 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.

K992608ATC OPTION FOR EVITA 2 DURA AND EVITA 4K984577DRAGER OXYLOG 2000K983219NEOFLOW OPTION MODEL NUMBERS 8413563, 8411900K982789MEDICAL AIR COMPRESSOR, MODEL # 8413419K980642EVITA 4 (8411900)K974176BABYLOG 8000 PLUS

View all 20 devices →

Related Devices (Code: CBK)

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.

K253647Evita (V800); Evita (V600)Draegerwerk AG & CO KgaaK252663Inbentus VersatileIconic Solutions by Murcia, SLK251888VPAP 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.

↑