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FDA 510(k)

INSTASPOT

K-Number: K942504 · 1995-05-05

ApplicantFidelity Medical, Inc.
Decision Date1995-05-05
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

INSTASPOT is the device name listed in this FDA 510(k) record. The listed applicant is Fidelity Medical, Inc.. It received FDA 510(k) clearance on 1995-05-05 under 510(k) number K942504. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INSTASPOT?

INSTASPOT is a medical device that received FDA 510(k) clearance on 1995-05-05. The listed applicant is Fidelity Medical, Inc.. The 510(k) number is K942504.

When did INSTASPOT receive FDA 510(k) clearance?

INSTASPOT received FDA 510(k) clearance on 1995-05-05, under 510(k) number K942504.

Who is the listed applicant for INSTASPOT?

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

What is the FDA product code for INSTASPOT?

The FDA product code for INSTASPOT is LLZ.

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Other records listing Fidelity 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.

K983088INSTACINE D-2000K942558INSTACINEK941917FLUOROPLUA CARDIAC AND/OR INSTAVIEWK903774LP-PLUSK872928LP-3000 HIGH RESOLUTION ELECTROCARDIOGRAPHK864614LP-3 ELECTROCARDIOGRAPH

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Related Devices (Code: LLZ)

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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