510(k) K851451
K851451 is an FDA 510(k) premarket notification submitted by Vulcan Laboratories, Inc. for the device "STAT GAS MODULE". The FDA issued a decision of Substantially Equivalent on August 2, 1985. The device falls under product code KLK (Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia), a Class II device regulated under 21 CFR 868.2500. Vulcan Laboratories, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 2, 1985
- Date Received
- April 11, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
- Device Class
- Class II
- Regulation Number
- 868.2500
- Review Panel
- AN
- Submission Type