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OXIFLOW DIGITAL RECORDER

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K953363
510(k) Type
Traditional
Applicant
EDENTEC CORP.
Country
United States
FDA Decision
Substantially Equivalent - Subject to Tracking Regulation
Decision Date
2/6/1996
Days to Decision
204 days

OXIFLOW DIGITAL RECORDER

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K953363
510(k) Type
Traditional
Applicant
EDENTEC CORP.
Country
United States
FDA Decision
Substantially Equivalent - Subject to Tracking Regulation
Decision Date
2/6/1996
Days to Decision
204 days