510(k) K810341
K810341 is an FDA 510(k) premarket notification submitted by Todd Industries, Inc. for the device "LIFELINE IPPB SET-UP". The FDA issued a decision of Substantially Equivalent on March 17, 1981. The device falls under product code BZO (Set, Tubing And Support, Ventilator (W Harness)), a Class I device regulated under 21 CFR 868.5975. Todd Industries, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 17, 1981
- Date Received
- February 10, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Set, Tubing And Support, Ventilator (W Harness)
- Device Class
- Class I
- Regulation Number
- 868.5975
- Review Panel
- AN
- Submission Type