510(k) K982331
K982331 is an FDA 510(k) premarket notification submitted by Keller Medical Specialties Products, Inc. for the device "KELLER PULSE OXIMETER, MODEL 850+". The FDA issued a decision of Substantially Equivalent on September 11, 1998. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Keller Medical Specialties Products, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 11, 1998
- Date Received
- July 2, 1998
- 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