510(k) K964821
K964821 is an FDA 510(k) premarket notification submitted by Ventrex, Inc. for the device "COVEROX SHEATH MODELS NUMBER PS65, PS67, EPS65 AND EPS67". The FDA issued a decision of Substantially Equivalent on July 16, 1997. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Ventrex, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 16, 1997
- Date Received
- December 2, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Oximeter
- Device Class
- Class II
- Regulation Number
- 870.2700
- Review Panel
- AN
- Submission Type