510(k) K914538
K914538 is an FDA 510(k) premarket notification submitted by Innovative Medical Products, Inc. for the device "UPH-2000 UNIVERSAL OXIMETRY PROBE HOLDER". The FDA issued a decision of Substantially Equivalent on July 14, 1992. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Innovative Medical Products, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 14, 1992
- Date Received
- October 11, 1991
- 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