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FDA 510(k)

PHILLY INFANT BOLT

K-Number: K840999 · 1984-04-04

ApplicantPhiladelphia Medical Specialties
Decision Date1984-04-04
Product CodeGWM
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

PHILLY INFANT BOLT 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 1984-04-04 under 510(k) number K840999. The device is classified under product code GWM. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHILLY INFANT BOLT?

PHILLY INFANT BOLT is a medical device that received FDA 510(k) clearance on 1984-04-04. The listed applicant is Philadelphia Medical Specialties. The 510(k) number is K840999.

When did PHILLY INFANT BOLT receive FDA 510(k) clearance?

PHILLY INFANT BOLT received FDA 510(k) clearance on 1984-04-04, under 510(k) number K840999.

Who is the listed applicant for PHILLY INFANT BOLT?

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 INFANT BOLT?

The FDA product code for PHILLY INFANT BOLT is GWM.

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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.

K834148PHILLY BOLTSK823459PHILLY BOLT ADULT PROCEDURE KITK822636CLASS II DEVICE FOR I.C.P. MONITORINGK820151PHILLY INFANT BOLTK813440PHILLY BOLT

Related Devices (Code: GWM)

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.

K252241Pressio 3 Multi-parameter Neuromonitoring SystemSophysaK250285NEUROVENT-P (092946-003); NEUROVENT (092956-003); NEUROVENT-IFD-R (095317-003); NEUROVENT-IFD-S (091678-003); NEUROVENT-P-TEMP (094268-003); NEUROVENT-TEMP (094278-003); NEUROVENT-TEMP-IFD-R (095327-003); NEUROVENT-TEMP-IFD-S (094288-003); NEUROVENT-PTO (095008-003); NEUROVENT-PTO 2L (095108-003); NEUROVENT-PX (091580-003); BOLT-DRILL KIT CH5 (091888-003); BOLT-DRILL KIT CH9 (091898-003); BOLT-DRILL KIT PTO (092380-003); BOLT-DRILL KIT VP 16 (092969-003); BOLT KIT CH5 (091868-003); BOLRaumedic AGK240821B4C System - Addition of new sensor model (BcSs-PICNIW-2000)Braincare Desenvolvimento E Inovação Tecnológica S.A.K232890CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)Integra Lifesciences Production CorporationK201989B4C SystemBraincare Desenvolvimento E Inovacao Tecnologica S.A.K210993CereLink ICP MonitorIntegra Lifesciences Production Corporation

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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