Last synced on 14 November 2025 at 11:06 pm

HALOFLEX ENERGY GENERATOR, MODELS 1190A-115A AND 1190A-230A

Page Type
Cleared 510(K)
510(k) Number
K092487
510(k) Type
Traditional
Applicant
BARRX MEDICAL, INCORPORATED
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/10/2009
Days to Decision
89 days
Submission Type
Summary

HALOFLEX ENERGY GENERATOR, MODELS 1190A-115A AND 1190A-230A

Page Type
Cleared 510(K)
510(k) Number
K092487
510(k) Type
Traditional
Applicant
BARRX MEDICAL, INCORPORATED
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/10/2009
Days to Decision
89 days
Submission Type
Summary