SPIRO PRO

Calculator, Predicted Values, Pulmonary Function

ERICH JAEGER GMBH

The following data is part of a premarket notification filed by Erich Jaeger Gmbh with the FDA for Spiro Pro.

Pre-market Notification Details

• Device ID: K000648
• 510k Number: K000648
• Device Name: SPIRO PRO
• Classification: Calculator, Predicted Values, Pulmonary Function
• Applicant: ERICH JAEGER GMBH 22705 SAVI RANCH PKWY. Yorba Linda, CA 92887 -4645
• Contact: Larry Murdock
• Correspondent: Larry Murdock; ERICH JAEGER GMBH 22705 SAVI RANCH PKWY. Yorba Linda, CA 92887 -4645
• Product Code: BTY
• CFR Regulation Number: 868.1890 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2000-02-28
• Decision Date: 2000-03-29