BOBES TONOMETER— 510(k) K945446

Substantially Equivalent

Bobes S.A.

FDA 510(k) clearance K945446 for BOBES TONOMETER, Substantially Equivalent on 1995-06-20. Applicant: Bobes S.A.. Device class: 2.

Clearance details

Applicant: Bobes S.A.
Product code: Code HKY
Device class: Class 2
Regulation: 21 CFR 886.1930
Advisory panel: Ophthalmic
Date received: 1994-11-07
Decision date: 1995-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Madrid, ES

Download summary PDF View on FDA.gov ↗

Recent devices under product code HKY

K241447 — iCare ST500 (TA04)2024-09-27
K233516 — Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318)2024-05-01
K234037 — CATS-L Tonometer Prism2024-02-09
K232143 — Applanation Tonometer HT-50002023-10-23
K220852 — iCare IC2002022-10-06

More clearances from Bobes S.A.

K945445 — BOBES SLIT LAMP1995-10-17
K945443 — BOBES LENS SET1995-07-19

Data sourced from openFDA. This site is unofficial and independent of the FDA.