510(k) K932709
K932709 is an FDA 510(k) premarket notification submitted by Precision Med Products, Ltd. for the device "PRECISION MED PRODUCTS LTD HYPERINFLATION SYSTEM". The FDA issued a decision of Substantially Equivalent on July 23, 1993. The device falls under product code BZR (Mixer, Breathing Gases, Anesthesia Inhalation), a Class II device regulated under 21 CFR 868.5330. Precision Med Products, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 23, 1993
- Date Received
- June 4, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mixer, Breathing Gases, Anesthesia Inhalation
- Device Class
- Class II
- Regulation Number
- 868.5330
- Review Panel
- AN
- Submission Type