AED Sinuscope

Nasopharyngoscope (flexible Or Rigid)

National Advanced Endoscopy Devices, Inc.

The following data is part of a premarket notification filed by National Advanced Endoscopy Devices, Inc. with the FDA for Aed Sinuscope.

Pre-market Notification Details

• Device ID: K170285
• 510k Number: K170285
• Device Name: AED Sinuscope
• Classification: Nasopharyngoscope (flexible Or Rigid)
• Applicant: National Advanced Endoscopy Devices, Inc. 22134 Sherman Way Canoga Park, CA 91303
• Contact: Gayle Butler
• Correspondent: Gayle Butler; National Advanced Endoscopy Devices, Inc. 22134 Sherman Way Canoga Park, CA 91303
• Product Code: EOB
• CFR Regulation Number: 874.4760 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-01-30
• Decision Date: 2017-08-01
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00848657085861	K170285	000
00848657006248	K170285	000
00848657006231	K170285	000
00848657006224	K170285	000
00848657006217	K170285	000
00848657006200	K170285	000
00848657006170	K170285	000
00848657087438	K170285	000
00848657087421	K170285	000
00848657087407	K170285	000
00848657087360	K170285	000
00848657087315	K170285	000
00848657087292	K170285	000
00848657087278	K170285	000
00848657087247	K170285	000
00848657086479	K170285	000
00848657086462	K170285	000
00848657006255	K170285	000
00848657006262	K170285	000
00848657085854	K170285	000
00848657013260	K170285	000
00848657006835	K170285	000
00848657006392	K170285	000
00848657006385	K170285	000
00848657006378	K170285	000
00848657006361	K170285	000
00848657006354	K170285	000
00848657006347	K170285	000
00848657006330	K170285	000
00848657006323	K170285	000
00848657006316	K170285	000
00848657006309	K170285	000
00848657006293	K170285	000
00848657006286	K170285	000
00848657006279	K170285	000
00848657015202	K170285	000