510(k) K770015
K770015 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "NOSECLIP FOR RESP. CARE & PULMON. FUNC.". The FDA issued a decision of Substantially Equivalent on March 16, 1977. The device falls under product code BXJ (Clip, Nose), a Class I device regulated under 21 CFR 868.6225. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 16, 1977
- Date Received
- January 3, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Clip, Nose
- Device Class
- Class I
- Regulation Number
- 868.6225
- Review Panel
- AN
- Submission Type