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FDA 510(k)

PHILLY BOLTS

K-Number: K834148 · 1984-02-10

ApplicantPhiladelphia Medical Specialties
Decision Date1984-02-10
Product CodeGWN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

PHILLY BOLTS is the device name listed in this FDA 510(k) record. The listed applicant is Philadelphia Medical Specialties. It received FDA 510(k) clearance on 1984-02-10 under 510(k) number K834148. The device is classified under product code GWN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHILLY BOLTS?

PHILLY BOLTS is a medical device that received FDA 510(k) clearance on 1984-02-10. The listed applicant is Philadelphia Medical Specialties. The 510(k) number is K834148.

When did PHILLY BOLTS receive FDA 510(k) clearance?

PHILLY BOLTS received FDA 510(k) clearance on 1984-02-10, under 510(k) number K834148.

Who is the listed applicant for PHILLY BOLTS?

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

What is the FDA product code for PHILLY BOLTS?

The FDA product code for PHILLY BOLTS is GWN.

Related Clinical Trials

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Other records listing Philadelphia Medical Specialties 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.

K840999PHILLY INFANT BOLTK823459PHILLY BOLT ADULT PROCEDURE KITK822636CLASS II DEVICE FOR I.C.P. MONITORINGK820151PHILLY INFANT BOLTK813440PHILLY BOLT

Related Devices (Code: GWN)

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.

K260566SMARTVERTIGO™ Vestibular Assessment SystemVertigoDx, Inc.K243709NeuroEars-Anna™Neuroears, Inc.K242198ICS Dizcovery (1091)Natus Medical Denmark ApsK242726Synapsys VHITInventis S.R.L.K223047NeuroSwift ProNeurobit Technologies Co., Ltd.K203082Insight Infrared Video GogglesVestibular First

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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