510(k) K000814
K000814 is an FDA 510(k) premarket notification submitted by Bhs Intl., Inc. for the device "FINGER PULSE METER". The FDA issued a decision of Substantially Equivalent on March 29, 2001. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Bhs Intl., Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 29, 2001
- Date Received
- March 13, 2000
- 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