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FDA 510(k)

APOLLO 95E

K-Number: K981948 · 1998-08-18

ApplicantDental/Medical Diagnostic Systems, Inc.
Decision Date1998-08-18
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

APOLLO 95E is the device name listed in this FDA 510(k) record. The listed applicant is Dental/Medical Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1998-08-18 under 510(k) number K981948. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the APOLLO 95E?

APOLLO 95E is a medical device that received FDA 510(k) clearance on 1998-08-18. The listed applicant is Dental/Medical Diagnostic Systems, Inc.. The 510(k) number is K981948.

When did APOLLO 95E receive FDA 510(k) clearance?

APOLLO 95E received FDA 510(k) clearance on 1998-08-18, under 510(k) number K981948.

Who is the listed applicant for APOLLO 95E?

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

What is the FDA product code for APOLLO 95E?

The FDA product code for APOLLO 95E is EBF.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Dental/Medical Diagnostic Systems, 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.

K990087DMD DIGITAL X-RAY SYSTEMK980474TELICAM

Related Devices (Code: EBF)

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.

K262982Core·it DualSpident Co., Ltd.K262202Cerasmart ForteGC America, Inc.K261695Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)Guilin Kevin Peter Technology Co., Ltd.K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc.K261246SRGC-06GC America, Inc.

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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