PACH-PEN CALCULATOR— 510(k) K884619

Substantially Equivalent

Oculab, Inc.

FDA 510(k) clearance K884619 for PACH-PEN CALCULATOR, Substantially Equivalent on 1989-02-02. Applicant: Oculab, Inc.. Device class: 2.

Clearance details

Applicant: Oculab, Inc.
Product code: Code DXG
Device class: Class 2
Regulation: 21 CFR 870.1435
Advisory panel: Cardiovascular
Date received: 1988-11-04
Decision date: 1989-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gendale, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Oculab, Inc.

K882750 — OCU-FILM TIP COVER1988-08-04
K862016 — PACH-PEN SURGICAL DRAPE1986-06-04
K860205 — BIO-PEN CALCULATOR1986-04-24
K860061 — OCULAB BIOMETRICPEN1986-03-10
K860062 — OCULAB PACHPEN1986-03-10

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