Last synced on 30 September 2022 at 11:05 pm

Microstream Advance Neonatal-Infant Nasal Filter Line with O2 Tubing, Microstream Advance Pediatric Oral-Nasal Filter Line with O2 Tubing, Microstream Advance Adult Oral-Nasal Filter Line with O2 Tubing, Microstream Luer Adult Oral-Nasal Sampling Line

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K181624
510(k) Type
Traditional
Applicant
Oridion Medical 1987 Ltd.
Country
Israel
FDA Decision
Substantially Equivalent
Decision Date
3/22/2019
Days to Decision
275 days
Submission Type
Summary

Microstream Advance Neonatal-Infant Nasal Filter Line with O2 Tubing, Microstream Advance Pediatric Oral-Nasal Filter Line with O2 Tubing, Microstream Advance Adult Oral-Nasal Filter Line with O2 Tubing, Microstream Luer Adult Oral-Nasal Sampling Line

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K181624
510(k) Type
Traditional
Applicant
Oridion Medical 1987 Ltd.
Country
Israel
FDA Decision
Substantially Equivalent
Decision Date
3/22/2019
Days to Decision
275 days
Submission Type
Summary