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FDA 510(k)

NOTTA AMBULATORY RECORDER

K-Number: K013450 · 2002-01-14

ApplicantStellate Systems
Decision Date2002-01-14
Product CodeOLV
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NOTTA AMBULATORY RECORDER is the device name listed in this FDA 510(k) record. The listed applicant is Stellate Systems. It received FDA 510(k) clearance on 2002-01-14 under 510(k) number K013450. The device is classified under product code OLV. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NOTTA AMBULATORY RECORDER?

NOTTA AMBULATORY RECORDER is a medical device that received FDA 510(k) clearance on 2002-01-14. The listed applicant is Stellate Systems. The 510(k) number is K013450.

When did NOTTA AMBULATORY RECORDER receive FDA 510(k) clearance?

NOTTA AMBULATORY RECORDER received FDA 510(k) clearance on 2002-01-14, under 510(k) number K013450.

Who is the listed applicant for NOTTA AMBULATORY RECORDER?

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

What is the FDA product code for NOTTA AMBULATORY RECORDER?

The FDA product code for NOTTA AMBULATORY RECORDER is OLV.

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Other records listing Stellate Systems as applicant

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Related Devices (Code: OLV)

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.

K261747Report StudioBeacon Biosignals, Inc.K260585Noxturnal WebNox Medical EhfK242447Falcon HSTCompumedics LimitedK241288Noxturnal WebNox Medical EhfK240700HomeSleepTest (HST, HST REM+)Somnomedics GmbHK213007Cerebra Sleep SystemCerebra Medical , Ltd.

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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