510(k) K851082
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