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FDA 510(k)

PACH-PEN CALCULATOR

K-Number: K884619 · 1989-02-02

ApplicantOculab, Inc.
Decision Date1989-02-02
Product CodeDXG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PACH-PEN CALCULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Oculab, Inc.. It received FDA 510(k) clearance on 1989-02-02 under 510(k) number K884619. The device is classified under product code DXG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PACH-PEN CALCULATOR?

PACH-PEN CALCULATOR is a medical device that received FDA 510(k) clearance on 1989-02-02. The listed applicant is Oculab, Inc.. The 510(k) number is K884619.

When did PACH-PEN CALCULATOR receive FDA 510(k) clearance?

PACH-PEN CALCULATOR received FDA 510(k) clearance on 1989-02-02, under 510(k) number K884619.

Who is the listed applicant for PACH-PEN CALCULATOR?

The FDA 510(k) record lists Oculab, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PACH-PEN CALCULATOR?

The FDA product code for PACH-PEN CALCULATOR is DXG.

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Other records listing Oculab, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K882750OCU-FILM TIP COVERK862016PACH-PEN SURGICAL DRAPEK860205BIO-PEN CALCULATORK860061OCULAB BIOMETRICPENK860062OCULAB PACHPENK852774OCULAB TONOPEN

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Related Devices (Code: DXG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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