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INFRARED GROUP AMPLIFICATION SYSTEM, INFRARED EMITTER, INFRARED BODY WORN RECEIVER, INFRARED HEADSET RECEIVER-STEREO, IT

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K974658
510(k) Type
Traditional
Applicant
PHONIC EAR, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/25/1998
Days to Decision
72 days
Submission Type
Summary

INFRARED GROUP AMPLIFICATION SYSTEM, INFRARED EMITTER, INFRARED BODY WORN RECEIVER, INFRARED HEADSET RECEIVER-STEREO, IT

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K974658
510(k) Type
Traditional
Applicant
PHONIC EAR, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/25/1998
Days to Decision
72 days
Submission Type
Summary