OLYMPUS BF TYPE UM40— 510(k) K021204
Substantially EquivalentOlympus Optical Co., Ltd.
FDA 510(k) clearance K021204 for OLYMPUS BF TYPE UM40, Substantially Equivalent on 2002-05-01. Applicant: Olympus Optical Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Olympus Optical Co., Ltd.
- Product code
- Code PSV
- Device class
- Class 2
- Regulation
- 21 CFR 892.1550
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Melville, NY, US
Recent devices under product code PSV
view allMore clearances from Olympus Optical Co., Ltd.
view all- K033225 — EVIS EXERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE XP160F, ITS ACCESSORIES AND ANCILLARY EQUIPMENT
- K031305 — OLYMPUS ULTRASONIC SURGICAL SYSTEM
- K031648 — VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V
- K032092 — OLYMPUS XCYF-TP3 CYSTOFIBERSCOPE/NEPHROFIBERSCOPE
- K031347 — ULTRASONIC GASTROVIDEOSCOPE, TYPE UC160P-AT8 AND UCT160-AT8
Adverse events under product code PSV
product code PSV- Death
- 6
- Injury
- 305
- Malfunction
- 3,705
- Total
- 4,016
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.