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MODEL AMI INFANT CENTRAL APHEA/HEART RATE MONITOR

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K961972
510(k) Type
Traditional
Applicant
AEQUITRON MEDICAL, INC.
Country
United States
FDA Decision
Substantially Equivalent - Subject to Tracking Regulation
Decision Date
4/18/1997
Days to Decision
333 days

MODEL AMI INFANT CENTRAL APHEA/HEART RATE MONITOR

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K961972
510(k) Type
Traditional
Applicant
AEQUITRON MEDICAL, INC.
Country
United States
FDA Decision
Substantially Equivalent - Subject to Tracking Regulation
Decision Date
4/18/1997
Days to Decision
333 days