0.6CC IONIZATION CHAMBER - WATERPROOF 0.6CC IONIZATION CHAMBER

Accelerator, Linear, Medical

PTW-NEW YORK CORP.

The following data is part of a premarket notification filed by Ptw-new York Corp. with the FDA for 0.6cc Ionization Chamber - Waterproof 0.6cc Ionization Chamber.

Pre-market Notification Details

• Device ID: K961208
• 510k Number: K961208
• Device Name: 0.6CC IONIZATION CHAMBER - WATERPROOF 0.6CC IONIZATION CHAMBER
• Classification: Accelerator, Linear, Medical
• Applicant: PTW-NEW YORK CORP. 2437 GRAND AVE. Bellmore, NY 11710
• Contact: Stephen R Szeglin
• Correspondent: Stephen R Szeglin; PTW-NEW YORK CORP. 2437 GRAND AVE. Bellmore, NY 11710
• Product Code: IYE
• CFR Regulation Number: 892.5050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1996-03-26
• Decision Date: 1996-06-17
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
EPTWTB233420	K961208	000
EPTWTM30010Y10	K961208	000
EPTWTM30010Y100	K961208	000
EPTWTM30011Y10	K961208	000
EPTWTM30011Y100	K961208	000
EPTWTM30012Y10	K961208	000
EPTWTM30012Y100	K961208	000
EPTWTM300130	K961208	000
EPTWTM300150	K961208	000
EPTWTM300160	K961208	000
EPTWTM340010	K961208	000
EPTWTM340130	K961208	000
EPTWTM340450	K961208	000
EPTWTM34070Y2Z50	K961208	000
EPTWTM34073Y1Z080	K961208	000
EPTWTM34080Y2Z50	K961208	000
EPTWTM34082Y2Z50	K961208	000
EPTWTM340910	K961208	000
EPTWTM233440	K961208	000
EPTWTM233430	K961208	000
EPTWTB233430	K961208	000
EPTWTB233440	K961208	000
EPTWTB30010Y10	K961208	000
EPTWTB30010Y100	K961208	000
EPTWTB30011Y10	K961208	000
EPTWTB30011Y100	K961208	000
EPTWTB30012Y10	K961208	000
EPTWTB30012Y100	K961208	000
EPTWTB300130	K961208	000
EPTWTB340010	K961208	000
EPTWTB340130	K961208	000
EPTWTB340450	K961208	000
EPTWTB34070Y2Z50	K961208	000
EPTWTB34080Y2Z50	K961208	000
EPTWTB34082Y2Z50	K961208	000
EPTWTL300130	K961208	000
EPTWTM233420	K961208	000
EPTWTN233420	K961208	000
EPTWTN233430	K961208	000
EPTWTN233440	K961208	000
EPTWTW233440	K961208	000
EPTWTW30010Y10	K961208	000
EPTWTW30010Y100	K961208	000
EPTWTW30011Y10	K961208	000
EPTWTW30011Y100	K961208	000
EPTWTW30012Y10	K961208	000
EPTWTW30012Y100	K961208	000
EPTWTW300130	K961208	000
EPTWTW300150	K961208	000
EPTWTW300160	K961208	000
EPTWTW340010	K961208	000
EPTWTW340130	K961208	000
EPTWTW340450	K961208	000
EPTWTW34070Y2Z50	K961208	000
EPTWTW34073Y1Z080	K961208	000
EPTWTW34080Y2Z50	K961208	000
EPTWTW34082Y2Z50	K961208	000
EPTWTW233430	K961208	000
EPTWTW233420	K961208	000
EPTWTN30010Y10	K961208	000
EPTWTN30010Y100	K961208	000
EPTWTN30011Y10	K961208	000
EPTWTN30011Y100	K961208	000
EPTWTN30012Y10	K961208	000
EPTWTN30012Y100	K961208	000
EPTWTN300130	K961208	000
EPTWTN300150	K961208	000
EPTWTN300160	K961208	000
EPTWTN340010	K961208	000
EPTWTN340130	K961208	000
EPTWTN340450	K961208	000
EPTWTN34070Y2Z50	K961208	000
EPTWTN34073Y1Z080	K961208	000
EPTWTN34080Y2Z50	K961208	000
EPTWTN34082Y2Z50	K961208	000
EPTWTN340910	K961208	000
EPTWTWN340910	K961208	000