510(k) K851082

V. MUELLER BLOM-SINGER ESOPHAGEAL INSUFFLATION TES by American V. Mueller — Product Code ENW

K851082 is an FDA 510(k) premarket notification submitted by American V. Mueller for the device "V. MUELLER BLOM-SINGER ESOPHAGEAL INSUFFLATION TES". The FDA issued a decision of Substantially Equivalent on July 22, 1985. The device falls under product code ENW (Catheter, Nasopharyngeal), a Class I device regulated under 21 CFR 874.4175. American V. Mueller has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 1985
Date Received
March 18, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Nasopharyngeal
Device Class
Class I
Regulation Number
874.4175
Review Panel
EN
Submission Type