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FDA 510(k)

SINGH SPEECH SYSTEM (SERIES 'SSS')

K-Number: K912486 · 1992-09-04

ApplicantExmoor Plastics , Ltd.
Decision Date1992-09-04
Product CodeEWL
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

SINGH SPEECH SYSTEM (SERIES 'SSS') is the device name listed in this FDA 510(k) record. The listed applicant is Exmoor Plastics , Ltd.. It received FDA 510(k) clearance on 1992-09-04 under 510(k) number K912486. The device is classified under product code EWL. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SINGH SPEECH SYSTEM (SERIES 'SSS')?

SINGH SPEECH SYSTEM (SERIES 'SSS') is a medical device that received FDA 510(k) clearance on 1992-09-04. The listed applicant is Exmoor Plastics , Ltd.. The 510(k) number is K912486.

When did SINGH SPEECH SYSTEM (SERIES 'SSS') receive FDA 510(k) clearance?

SINGH SPEECH SYSTEM (SERIES 'SSS') received FDA 510(k) clearance on 1992-09-04, under 510(k) number K912486.

Who is the listed applicant for SINGH SPEECH SYSTEM (SERIES 'SSS')?

The FDA 510(k) record lists Exmoor Plastics , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SINGH SPEECH SYSTEM (SERIES 'SSS')?

The FDA product code for SINGH SPEECH SYSTEM (SERIES 'SSS') is EWL.

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Other records listing Exmoor Plastics , Ltd. 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.

K093863EPIDRUMK990366EXMOOR SUCTION CLEARANCE KITK980828EXMOOR MYRINGOTOMY KITK981143DILKES LASER/SUCTION CANNULAEK972700EXMOOR ATTIC AND MASTOID ANTRUM MIDDLE EAR IMPLANT (EMMETT CAMPBELL MD FACS PATTERN)K981088MILLS COLUMELLA PROSTHESIS

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Related Devices (Code: EWL)

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.

K240763FirstFit Surgical KitFreudenberg Medical, LLCK131947PROVOX VEGA PUNCTURE SETAtos Medical ABK092593PROVOX ACTIVALVE (SIZE 4.5MM, 6MM, 8MM, 10MM, 12.5MM)Atos Medical ABK093258BLOM-SINGER INDWELLING TEP OCCLUDERHelix Medical, LLCK090455PROVOX VEGA, MODEL 8130-8135Atos Medical ABK082206BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES, DV-2000 SERIESHelix Medical, LLC

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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