510(k) K770631
K770631 is an FDA 510(k) premarket notification submitted by Instrumentation Industries, Inc. for the device "FLEX ARM BE 122, CLAMP 122-27". The FDA issued a decision of Substantially Equivalent on May 23, 1977. The device falls under product code JAY (Support, Breathing Tube), a Class I device regulated under 21 CFR 868.5280. Instrumentation Industries, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 23, 1977
- Date Received
- April 4, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Support, Breathing Tube
- Device Class
- Class I
- Regulation Number
- 868.5280
- Review Panel
- AN
- Submission Type