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510(k) Data Aggregation
K Number
K973972Device Name
PERFECT EAR/ MINI-CANAL/ PE-M, PE-ML, PE-MD), PERFECT EAR/ C.I.C./ (PEC, PE-CD) (WITH OR WITHOUT RID-WAX BARRIER)
Manufacturer
Date Cleared
1997-11-04
(15 days)
Product Code
Regulation Number
874.3300Why did this record match?
Applicant Name (Manufacturer) :
PERFECT EAR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A. General Indications: The indication for use of the air conduction hearing aids in this submission is to amplify sound for individuals with impaired hearing. The devices are indicated for individuals with losses in the following category(ies). Severity: X 1. Slight X 2. Mild X 3. Moderate Configuration: X 1. High Frequency - Precipitously Sloping X 2. Gradually Sloping X 3. Reverse Slope X 4. Flat Other 1. Low Tolerance To Loudness B. Specific Indications (Only if appropriate.) : (Most psychoacoustic indications such as improved speech intelligibility in background noise, must be supported by clinical data.)
Device Description
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K Number
K960410Device Name
PERFECT EAR PE/PE-AGC/PE-B/PE-PWR
Manufacturer
Date Cleared
1996-04-04
(66 days)
Product Code
Regulation Number
874.3300Why did this record match?
Applicant Name (Manufacturer) :
PERFECT EAR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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