PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System
K-Number: K213235 · 2022-12-21
Device Summary
Frequently Asked Questions
What is the PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System?
PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System is a medical device that received FDA 510(k) clearance on 2022-12-21. The listed applicant is Pentax of America, Inc.. The 510(k) number is K213235.
When did PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System receive FDA 510(k) clearance?
PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System received FDA 510(k) clearance on 2022-12-21, under 510(k) number K213235.
Who is the listed applicant for PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System?
The FDA 510(k) record lists Pentax of America, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System?
The FDA product code for PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System is EOQ.
Other records listing Pentax of America, Inc. as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: EOQ)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.