510(k) K873078
K873078 is an FDA 510(k) premarket notification submitted by Novametrix Medical Systems, Inc. for the device "NOVAMETRIX MODEL 505 PULSE OXIMETER". The FDA issued a decision of Substantially Equivalent on September 23, 1987. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Novametrix Medical Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 23, 1987
- Date Received
- August 5, 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