EXONIX— 510(k) K984199
Substantially EquivalentFibra Sonics, Inc.
FDA 510(k) clearance K984199 for EXONIX, Substantially Equivalent on 1999-02-17. Applicant: Fibra Sonics, Inc.. Device class: 2.
Clearance details
- Applicant
- Fibra Sonics, Inc.
- Product code
- Code IMI
- Device class
- Class 2
- Regulation
- 21 CFR 890.5300
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chicago, IL, US
Recent devices under product code IMI
view allMore clearances from Fibra Sonics, Inc.
view all- K993046 — FIBRA SONICS ULTRASONIC LITHOTRIPTOR LITHOSONIC, MODEL LS-2000
- K984143 — FIBRA-SONICS PHACO III OR IIIP FRAGMENTATION SYSTEM
- K983199 — FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 1000 CONSOLE MODEL
- K980930 — FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 2100 USSTA
- K842024 — ULTRASONIC LITHOTRIPTOR 300A
Data sourced from openFDA. This site is unofficial and independent of the FDA.