EUB-165— 510(k) K895326
Substantially EquivalentHitachi Medical Corp. of America
FDA 510(k) clearance K895326 for EUB-165, Substantially Equivalent on 1990-03-22. Applicant: Hitachi Medical Corp. of America. Device class: 2.
Clearance details
- Applicant
- Hitachi Medical Corp. of America
- Product code
- Code DXK
- Device class
- Class 2
- Regulation
- 21 CFR 870.2330
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tarrytown, NY, US
Recent devices under product code DXK
view allMore clearances from Hitachi Medical Corp. of America
view all- K994026 — EUB-6000 ULTRASOUND DIAGNOSTIC SCANNER
- K991535 — CONVERGENCE CDR FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS
- K991318 — CONVERGENCE NUA FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS
- K991129 — HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERA SYSTEM WITH THICK NAL(TI) CRYSTAL
- K981434 — EUP-OL334 LAPARASCOPICPROBE
Data sourced from openFDA. This site is unofficial and independent of the FDA.