510(k) K820370
K820370 is an FDA 510(k) premarket notification submitted by American Pharmaseal Div. Ahsc for the device "NASAL OXYGEN CATHETER". The FDA issued a decision of Substantially Equivalent on April 16, 1982. The device falls under product code BZB (Catheter, Nasal, Oxygen), a Class I device regulated under 21 CFR 868.5350. American Pharmaseal Div. Ahsc has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 16, 1982
- Date Received
- February 9, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Nasal, Oxygen
- Device Class
- Class I
- Regulation Number
- 868.5350
- Review Panel
- AN
- Submission Type