Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

QUILTONE MODEL 48 PP-AGC-I-D-BEHIND THE EAR

K-Number: K912153 · 1991-06-17

ApplicantQualitone
Decision Date1991-06-17
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

QUILTONE MODEL 48 PP-AGC-I-D-BEHIND THE EAR is the device name listed in this FDA 510(k) record. The listed applicant is Qualitone. It received FDA 510(k) clearance on 1991-06-17 under 510(k) number K912153. The device is classified under product code ESD. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUILTONE MODEL 48 PP-AGC-I-D-BEHIND THE EAR?

QUILTONE MODEL 48 PP-AGC-I-D-BEHIND THE EAR is a medical device that received FDA 510(k) clearance on 1991-06-17. The listed applicant is Qualitone. The 510(k) number is K912153.

When did QUILTONE MODEL 48 PP-AGC-I-D-BEHIND THE EAR receive FDA 510(k) clearance?

QUILTONE MODEL 48 PP-AGC-I-D-BEHIND THE EAR received FDA 510(k) clearance on 1991-06-17, under 510(k) number K912153.

Who is the listed applicant for QUILTONE MODEL 48 PP-AGC-I-D-BEHIND THE EAR?

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

What is the FDA product code for QUILTONE MODEL 48 PP-AGC-I-D-BEHIND THE EAR?

The FDA product code for QUILTONE MODEL 48 PP-AGC-I-D-BEHIND THE EAR is ESD.

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 Qualitone 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.

K961827IN-THE-EARK955466DYNAMEQ-II OPTIONK955359CYBER III OPTION UM, UC312, UC10, UCICK953884PROPHETK935348ODYSSEY CLINICAL AUDIOMETERK935289PRO FIT-CYBER II OPTION

View all 39 devices →

Related Devices (Code: ESD)

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.

K232999Lyric4 Hearing AidSonova AGK130790LYRIC2Phonak, LLCK081136LYRIC HEARING AIDInsound Medical, Inc.K021867INSOUND XT SERIES HEARING AIDInsound Medical, Inc.K003558TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)Siemens Hearing Instruments, Inc.K984518SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELLSonic Innovations, 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.

↑