510(k) K924978
K924978 is an FDA 510(k) premarket notification submitted by Puritan Bennett Corp. for the device "7250 METABOLIC MONITOR". The FDA issued a decision of Substantially Equivalent on September 22, 1994. The device falls under product code BZL (Computer, Oxygen-Uptake), a Class II device regulated under 21 CFR 868.1730. Puritan Bennett Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 22, 1994
- Date Received
- October 1, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Computer, Oxygen-Uptake
- Device Class
- Class II
- Regulation Number
- 868.1730
- Review Panel
- AN
- Submission Type