VDR SINUSOIDAL PERCUSIONATOR FAMILY/RELATE ACCESS

Ventilator, Continuous, Facility Use

PERCUSSIONAIRE CORP.

The following data is part of a premarket notification filed by Percussionaire Corp. with the FDA for Vdr Sinusoidal Percusionator Family/relate Access.

Pre-market Notification Details

• Device ID: K905235
• 510k Number: K905235
• Device Name: VDR SINUSOIDAL PERCUSIONATOR FAMILY/RELATE ACCESS
• Classification: Ventilator, Continuous, Facility Use
• Applicant: PERCUSSIONAIRE CORP. BIRD AIRLODGE, GLENGARY BAY P.O. BOX 817 Sandpoint, ID 83864
• Contact: Forrest M Bird
• Correspondent: Forrest M Bird; PERCUSSIONAIRE CORP. BIRD AIRLODGE, GLENGARY BAY P.O. BOX 817 Sandpoint, ID 83864
• Product Code: CBK
• CFR Regulation Number: 868.5895 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1990-11-07
• Decision Date: 1991-05-03

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00849436000556	K905235	000
10849436000195	K905235	000
00849436000044	K905235	000
00849436000051	K905235	000
00849436000068	K905235	000
00849436000228	K905235	000
00849436000235	K905235	000
10849436000256	K905235	000
00849436000297	K905235	000
10849436000331	K905235	000
00849436000471	K905235	000
00849436000662	K905235	000