510(k) K001502
K001502 is an FDA 510(k) premarket notification submitted by Erich Jaeger GmbH for the device "AEROSOL PROVOCATION SYSTEM APS PRO, MODEL APS PRO". The FDA issued a decision of Substantially Equivalent on July 12, 2000. The device falls under product code BZC (Calculator, Pulmonary Function Data), a Class II device regulated under 21 CFR 868.1880. Erich Jaeger GmbH has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 12, 2000
- Date Received
- May 15, 2000
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Calculator, Pulmonary Function Data
- Device Class
- Class II
- Regulation Number
- 868.1880
- Review Panel
- AN
- Submission Type