Antistatic Compact Space Chamber

Holding Chambers, Direct Patient Interface

MEDICAL DEVELOPMENTS INTERNATIONAL LIMITED

The following data is part of a premarket notification filed by Medical Developments International Limited with the FDA for Antistatic Compact Space Chamber.

Pre-market Notification Details

• Device ID: K143615
• 510k Number: K143615
• Device Name: Antistatic Compact Space Chamber
• Classification: Holding Chambers, Direct Patient Interface
• Applicant: MEDICAL DEVELOPMENTS INTERNATIONAL LIMITED 7/56 SMITH ROAD Springvale, AU 3171
• Contact: Maggie Oh
• Correspondent: Maggie Oh; MEDICAL DEVELOPMENTS INTERNATIONAL LIMITED 7/56 SMITH ROAD Springvale, AU 3171
• Product Code: NVP
• CFR Regulation Number: 868.5630 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-12-19
• Decision Date: 2016-01-26

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00842135100039	K143615	000
00842135100022	K143615	000
10842135100012	K143615	000
00842135100008	K143615	000
00842135100015	K143615	000