Last synced on 20 May 2022 at 11:05 pm

SHINEBALL PVC MANUAL RESUSCIATOR, ENT-1001, ENT-1003, ENT-1005, SHINEBALL SILICONE MANUAL RESUSCIATOR, ENT-1022,

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K042556
510(k) Type
Traditional
Applicant
ENTER MEDICAL CORPORATION
Country
Taiwan
FDA Decision
Substantially Equivalent
Decision Date
3/11/2005
Days to Decision
172 days
Submission Type
Summary

SHINEBALL PVC MANUAL RESUSCIATOR, ENT-1001, ENT-1003, ENT-1005, SHINEBALL SILICONE MANUAL RESUSCIATOR, ENT-1022,

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K042556
510(k) Type
Traditional
Applicant
ENTER MEDICAL CORPORATION
Country
Taiwan
FDA Decision
Substantially Equivalent
Decision Date
3/11/2005
Days to Decision
172 days
Submission Type
Summary