510(k) K874198
K874198 is an FDA 510(k) premarket notification submitted by Vitalog Corp. for the device "VITALOG HMS-3000". The FDA issued a decision of Substantially Equivalent on March 22, 1988. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Vitalog Corp. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 22, 1988
- Date Received
- October 9, 1987
- 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