510(k) K992421
K992421 is an FDA 510(k) premarket notification submitted by Accutron, Inc. for the device "GUARDIAN LOW PRESSURE ALARM ACCESSORY, MODEL 34076". The FDA issued a decision of Substantially Equivalent on October 27, 1999. The device falls under product code BSZ (Gas-Machine, Anesthesia), a Class II device regulated under 21 CFR 868.5160. Accutron, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 27, 1999
- Date Received
- July 21, 1999
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Gas-Machine, Anesthesia
- Device Class
- Class II
- Regulation Number
- 868.5160
- Review Panel
- AN
- Submission Type