510(k) K960044

Device: ULTRAMAX/MODEL NUMBER A1
Applicant: ENTLAB OY
510(k) number: K960044
Product code: LWI
Decision: Substantially Equivalent (SESE)
Decision date: 1996-08-02
Date received: 1996-01-02
Regulation: 892.1560
Classification name: Ultrasound, Sinus
Medical specialty: Radiology
Review panel: Radiology
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: MATTI REVONTA
Address: 5671 Sandiford Pl. Richmond CA V7E 5M5 V7E 5M5

Source Documents#

Other 510(k) Records For Product Code LWI #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K960421	SINUSCAN 102/SINUSPRINT	Ferguson Medical	1997-04-16
K960241	CPR GENERAL SURGERY TRAY	Custom Pack Reliability	1996-03-22
K874081	ENTERSCAN	Pie Data Medical BV	1987-12-31

Legacy Summary#

summary

FDA Review#

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