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FDA 510(k)

SANDBOX I, SANDBOX II, SANDBOX JR.

K-Number: K903321 · 1991-02-19

ApplicantSandbox Ent.
Decision Date1991-02-19
Product CodeIRT
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SANDBOX I, SANDBOX II, SANDBOX JR. is the device name listed in this FDA 510(k) record. The listed applicant is Sandbox Ent.. It received FDA 510(k) clearance on 1991-02-19 under 510(k) number K903321. The device is classified under product code IRT. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SANDBOX I, SANDBOX II, SANDBOX JR.?

SANDBOX I, SANDBOX II, SANDBOX JR. is a medical device that received FDA 510(k) clearance on 1991-02-19. The listed applicant is Sandbox Ent.. The 510(k) number is K903321.

When did SANDBOX I, SANDBOX II, SANDBOX JR. receive FDA 510(k) clearance?

SANDBOX I, SANDBOX II, SANDBOX JR. received FDA 510(k) clearance on 1991-02-19, under 510(k) number K903321.

Who is the listed applicant for SANDBOX I, SANDBOX II, SANDBOX JR.?

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

What is the FDA product code for SANDBOX I, SANDBOX II, SANDBOX JR.?

The FDA product code for SANDBOX I, SANDBOX II, SANDBOX JR. is IRT.

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Related Devices (Code: IRT)

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Official Source

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

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