PeriFLEX

Bronchoscope (flexible Or Rigid)

SPIRATION, INC.

The following data is part of a premarket notification filed by Spiration, Inc. with the FDA for Periflex.

Pre-market Notification Details

• Device ID: K162611
• 510k Number: K162611
• Device Name: PeriFLEX
• Classification: Bronchoscope (flexible Or Rigid)
• Applicant: SPIRATION, INC. 6675 185TH AVE NE Redmond, WA 98052
• Contact: Aadarsh S Viswanathan
• Correspondent: Aadarsh S. Viswanathan; SPIRATION, INC. 6675 185TH AVE NE Redmond, WA 98052
• Product Code: EOQ
• CFR Regulation Number: 874.4680 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-09-19
• Decision Date: 2017-02-09
• Summary: summary