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GUARDIAN NEONATE CPAP/HUMIDIFICATION SYSTEM

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K040862
510(k) Type
Traditional
Applicant
CARADYNE, LTD.
Country
Ireland
FDA Decision
Substantially Equivalent
Decision Date
6/30/2004
Days to Decision
89 days
Submission Type
Summary

GUARDIAN NEONATE CPAP/HUMIDIFICATION SYSTEM

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K040862
510(k) Type
Traditional
Applicant
CARADYNE, LTD.
Country
Ireland
FDA Decision
Substantially Equivalent
Decision Date
6/30/2004
Days to Decision
89 days
Submission Type
Summary