DEVILBISS PULMO-AIDE COMPACT COMPRESSOR

Nebulizer (direct Patient Interface)

SUNRISE MEDICAL

The following data is part of a premarket notification filed by Sunrise Medical with the FDA for Devilbiss Pulmo-aide Compact Compressor.

Pre-market Notification Details

• Device ID: K020932
• 510k Number: K020932
• Device Name: DEVILBISS PULMO-AIDE COMPACT COMPRESSOR
• Classification: Nebulizer (direct Patient Interface)
• Applicant: SUNRISE MEDICAL 100 DEVILBISS DR. Somerset, PA 15501
• Contact: Ray Hoffman
• Product Code: CAF
• CFR Regulation Number: 868.5630 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2002-03-22
• Decision Date: 2002-06-28
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00085304001508	K020932	000
10885304001444	K020932	000
00885304001430	K020932	000
00885304001355	K020932	000
10885304001284	K020932	000
10885304001260	K020932	000
10885304001253	K020932	000
00885304001249	K020932	000
10885304001185	K020932	000
10885304001048	K020932	000
00885304000570	K020932	000
10885304000232	K020932	000
10885304000133	K020932	000
10885304000072	K020932	000
00885304007142	K020932	000
00853040015080	K020932	000
10885304001505	K020932	000
00885304022268	K020932	000
00885304001454	K020932	000
00885304001492	K020932	000
01008530402265	K020932	000
10885304009495	K020932	000
10885304009488	K020932	000
00885304009474	K020932	000
00885304008224	K020932	000
10885304002311	K020932	000
10885304001833	K020932	000
00885304001805	K020932	000
10885304001789	K020932	000
00885304001775	K020932	000
00885304001751	K020932	000
00885304001690	K020932	000
1088304001673	K020932	000
10885304001635	K020932	000
10885304001604	K020932	000
10885304001536	K020932	000
00885304001515	K020932	000
00885304001676	K020932	000