510(k) K973991
K973991 is an FDA 510(k) premarket notification submitted by Metron U.S., Inc. for the device "METRON QA-510 SPO2 ANALYZER". The FDA issued a decision of Substantially Equivalent on January 16, 1998. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Metron U.S., Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 16, 1998
- Date Received
- October 21, 1997
- 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