510(k) K981845
K981845 is an FDA 510(k) premarket notification submitted by Medical Industrial Equipment for the device "HAWK ANAESTHESIA INDUCTION UNIT". The FDA issued a decision of Substantially Equivalent on November 3, 1998. The device falls under product code BSZ (Gas-Machine, Anesthesia), a Class II device regulated under 21 CFR 868.5160. Medical Industrial Equipment has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 3, 1998
- Date Received
- May 26, 1998
- Clearance Type
- Traditional
- 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