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FDA 510(k)

BODY BOX 5500

K-Number: K022636 · 2003-01-13

ApplicantMorgan Scientific, Inc.
Decision Date2003-01-13
Product CodeJEH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BODY BOX 5500 is the device name listed in this FDA 510(k) record. The listed applicant is Morgan Scientific, Inc.. It received FDA 510(k) clearance on 2003-01-13 under 510(k) number K022636. The device is classified under product code JEH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BODY BOX 5500?

BODY BOX 5500 is a medical device that received FDA 510(k) clearance on 2003-01-13. The listed applicant is Morgan Scientific, Inc.. The 510(k) number is K022636.

When did BODY BOX 5500 receive FDA 510(k) clearance?

BODY BOX 5500 received FDA 510(k) clearance on 2003-01-13, under 510(k) number K022636.

Who is the listed applicant for BODY BOX 5500?

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

What is the FDA product code for BODY BOX 5500?

The FDA product code for BODY BOX 5500 is JEH.

Other records listing Morgan Scientific, 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.

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Related Devices (Code: JEH)

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.

K240706PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); PowerCube+ Series (PowerCube Body+ / Diffusion+)Ganshorn Medizin Electronic GmbHK223818Model 9160 VitaloQUBVitalograph Ireland, Ltd.K072061MASTERSCREEN PFT, MASTERSCREEN PFT CT, MASTERSCREEN PFT BODYViasys Healthcare GmbHK960840C.E. VASCULAR MACHINEC.E. Diagnosis, Inc.K953642AP-18Jeneric/Pentron, Inc.K951901MASTERSCREEN PFT BODYErich Jaeger GmbH & Co. KG

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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