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)

EMERSON CHEST RESPIRATOR, MODEL 33-CRE

K-Number: K881808 · 1988-08-04

ApplicantJ. H. Emerson Co.
Decision Date1988-08-04
Product CodeBYT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

EMERSON CHEST RESPIRATOR, MODEL 33-CRE is the device name listed in this FDA 510(k) record. The listed applicant is J. H. Emerson Co.. It received FDA 510(k) clearance on 1988-08-04 under 510(k) number K881808. The device is classified under product code BYT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMERSON CHEST RESPIRATOR, MODEL 33-CRE?

EMERSON CHEST RESPIRATOR, MODEL 33-CRE is a medical device that received FDA 510(k) clearance on 1988-08-04. The listed applicant is J. H. Emerson Co.. The 510(k) number is K881808.

When did EMERSON CHEST RESPIRATOR, MODEL 33-CRE receive FDA 510(k) clearance?

EMERSON CHEST RESPIRATOR, MODEL 33-CRE received FDA 510(k) clearance on 1988-08-04, under 510(k) number K881808.

Who is the listed applicant for EMERSON CHEST RESPIRATOR, MODEL 33-CRE?

The FDA 510(k) record lists J. H. Emerson Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EMERSON CHEST RESPIRATOR, MODEL 33-CRE?

The FDA product code for EMERSON CHEST RESPIRATOR, MODEL 33-CRE is BYT.

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 J. H. Emerson Co. 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.

K002598EMERSON COUGH ASSIST MODEL CA-3000 W/AUTOMATIC TIMING AND MODEL CM-3000 W/MANUAL TIMINGK920910OXYGEN POWERED RESUSCITATOR FOR CPRK924174EMERSON IN-EXSUFFLATOR, MODELS 2-CM & 2-CAK902764EMERSON 33-AN NEGATIVE PRESSURE RESPIRATOR ALARMK896721MODEL 7-AT TREATMENT CHAMBERK873489EMERSON DISPOS THORACIC DRAINAGE SET - 551-8000

View all 25 devices →

Related Devices (Code: BYT)

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.

K082657RTX RESPIRATORMedivent LimitedK072290PEGASO V, NEGAVENT RESPIRATOR, MODEL: DA-3 PLUSDima Italia SrlK924341HAYEK OSCILLATOR(TM)Respironics, Inc.K910947NEV-10 NEGATIVE PRESSURE VENTILATORLifecare Services, Inc.K905530PURITAN-BENNETT COMPANION 500 LIQUID OXYGEN SYSTEMPuritan Bennett Corp.K902764EMERSON 33-AN NEGATIVE PRESSURE RESPIRATOR ALARMJ. H. Emerson Co.

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.

↑