Reprocessed Bronchoscope

QNW · Class II — Moderate Risk (510(k) clearance required) · Ear, Nose, Throat · 21 CFR 874.4680

Classification

FDA Product Code: QNW
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 874.4680
Review panel: EN
Medical specialty: Ear, Nose, Throat
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

Same as EOQ except reprocessed. Please see EOQ at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=EOQ Reprocessing validation data for this device type must be included in a 510(k) submission.

Market data

Cleared 510(k) submissions: 2
Registered establishments: 8

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown