510(k) K962871
K962871 is an FDA 510(k) premarket notification submitted by Reimers Systems, Inc. for the device "ODS1 - HOOD DRIVER". The FDA issued a decision of Substantially Equivalent on October 23, 1996. The device falls under product code CBF (Chamber, Hyperbaric), a Class II device regulated under 21 CFR 868.5470. Reimers Systems, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 23, 1996
- Date Received
- July 23, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Chamber, Hyperbaric
- Device Class
- Class II
- Regulation Number
- 868.5470
- Review Panel
- AN
- Submission Type