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FDA 510(k)

AUDICOR 200 SYSTEM, MODELS 200D AND 200S

K-Number: K070136 · 2007-04-13

ApplicantInovise Medical, Inc.
Decision Date2007-04-13
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AUDICOR 200 SYSTEM, MODELS 200D AND 200S is the device name listed in this FDA 510(k) record. The listed applicant is Inovise Medical, Inc.. It received FDA 510(k) clearance on 2007-04-13 under 510(k) number K070136. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUDICOR 200 SYSTEM, MODELS 200D AND 200S?

AUDICOR 200 SYSTEM, MODELS 200D AND 200S is a medical device that received FDA 510(k) clearance on 2007-04-13. The listed applicant is Inovise Medical, Inc.. The 510(k) number is K070136.

When did AUDICOR 200 SYSTEM, MODELS 200D AND 200S receive FDA 510(k) clearance?

AUDICOR 200 SYSTEM, MODELS 200D AND 200S received FDA 510(k) clearance on 2007-04-13, under 510(k) number K070136.

Who is the listed applicant for AUDICOR 200 SYSTEM, MODELS 200D AND 200S?

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

What is the FDA product code for AUDICOR 200 SYSTEM, MODELS 200D AND 200S?

The FDA product code for AUDICOR 200 SYSTEM, MODELS 200D AND 200S is DPS.

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Other records listing Inovise Medical, 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.

K151433AUDICOR CA300/CC100 Analyzer with SDBK130660AUDICOR CPAM WITH SDB (SINGLE SENSOR)K120462AUDICOR CPAM WITH SDB (CARDIOPULMONARY AMBULATORY MONITOR WITH SLEEP DISORDERED BREATHING DETECTION)K110569AUDICOR CPAM (CARDIOPULMONARY AMBULATORY MONITOR)K103516AUDICOR SENSOR-ADAPTER MODEL AUDICOR SENSOR-ADAPTER 4.0K080602AUDICOR SENSOR, MODELS: 2.0, 3.0

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Related Devices (Code: DPS)

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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