510(k) K760891

Device: INSPIRON I.M.V. SET UP
Applicant: INSPIRON CORP.
510(k) number: K760891
Product code: CBO
Decision: Substantially Equivalent (SESE)
Decision date: 1976-12-09
Date received: 1976-10-26
Regulation: 868.5955
Classification name: Attachment, Intermittent Mandatory Ventilation (imv)
Medical specialty: Anesthesiology
Review panel: Anesthesiology
Device class: 2
Clearance type: Traditional
Third party reviewed: No

Applicant Contact#

Address: 803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

3011137372
1924066
3004365956

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code CBO #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K811991	SIMVAC	The Lynn Terrell Co.	1981-08-12
K811908	IMV MANIFOLDS	Airlife, Inc.	1981-07-16
K791904	IMV W/BAG & HOSES #M-509	Mem Medical, Inc.	1979-10-09
K791905	IMV W/BAG & TUBING #M-508	Mem Medical, Inc.	1979-10-09
K791906	IMV W/BAG #M-507	Mem Medical, Inc.	1979-10-09
K791909	IMV BUSHING #M-513	Mem Medical, Inc.	1979-10-09
K791911	FALL-SAFE IMV #M-511	Mem Medical, Inc.	1979-10-09
K791912	IMV FOR MONITORING #M-510	Mem Medical, Inc.	1979-10-09
K791913	IMV MANIFOLD #M-506	Mem Medical, Inc.	1979-10-09
K781706	RESPIRATOR/GILL 1/SIMV	Chemetron Medical Products, Inc.	1979-01-22
K760680	INTERMITTENT MANDATORY VENTILATION	B & F Medical Products, Inc.	1976-09-27
K760263	I.P.P.B. MANIFOLD/NEBULIZER (CIRCUIT)	Foregger	1976-08-04
K760221	I.P.P.B., DIS. W/MANIFOLD/NEBULIZER	Manner Medical Products	1976-08-03
K760039	VALVE, I.M.V. (U-MID ONE WAY)	Bd Becton Dickinson Vacutainer Systems Preanalytic	1976-07-16

Legacy Summary#

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