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FDA 510(k)

RECTOSIGHT RS 300-04

K-Number: K994130 · 2000-06-30

ApplicantSightline Technologies , Ltd.
Decision Date2000-06-30
Product CodeFER
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

RECTOSIGHT RS 300-04 is the device name listed in this FDA 510(k) record. The listed applicant is Sightline Technologies , Ltd.. It received FDA 510(k) clearance on 2000-06-30 under 510(k) number K994130. The device is classified under product code FER. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RECTOSIGHT RS 300-04?

RECTOSIGHT RS 300-04 is a medical device that received FDA 510(k) clearance on 2000-06-30. The listed applicant is Sightline Technologies , Ltd.. The 510(k) number is K994130.

When did RECTOSIGHT RS 300-04 receive FDA 510(k) clearance?

RECTOSIGHT RS 300-04 received FDA 510(k) clearance on 2000-06-30, under 510(k) number K994130.

Who is the listed applicant for RECTOSIGHT RS 300-04?

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

What is the FDA product code for RECTOSIGHT RS 300-04?

The FDA product code for RECTOSIGHT RS 300-04 is FER.

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Other records listing Sightline Technologies , Ltd. 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.

K032688COLONOSIGHT MODEL 510BK011825RECTOSIGHT RS300-04;AND PROTOSIGHT PS300-04 DEVICE

Related Devices (Code: FER)

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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