510(k) K853162
K853162 is an FDA 510(k) premarket notification submitted by Inmed Corp. for the device "STERILE NASOPHARYNGEAL AIRWAY". The FDA issued a decision of Substantially Equivalent on August 6, 1985. The device falls under product code BTQ (Airway, Nasopharyngeal), a Class I device regulated under 21 CFR 868.5100. Inmed Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 6, 1985
- Date Received
- July 30, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Airway, Nasopharyngeal
- Device Class
- Class I
- Regulation Number
- 868.5100
- Review Panel
- AN
- Submission Type