Last synced on 20 May 2022 at 11:05 pm

HOPE CONTINUOUS NEBULIZER MODEL HOPE-11310, HEART NEBULIZER MODEL HEART-100609, THERAMIST NEBULIZER MODEL THERAMIST-3100

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K122857
510(k) Type
Traditional
Applicant
PEGASUS RESEARCH CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/7/2012
Days to Decision
50 days
Submission Type
Statement

HOPE CONTINUOUS NEBULIZER MODEL HOPE-11310, HEART NEBULIZER MODEL HEART-100609, THERAMIST NEBULIZER MODEL THERAMIST-3100

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K122857
510(k) Type
Traditional
Applicant
PEGASUS RESEARCH CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/7/2012
Days to Decision
50 days
Submission Type
Statement