OSCILLAIRE

Calculator, Pulmonary Function Data

JONES MEDICAL INSTRUMENT CO.

The following data is part of a premarket notification filed by Jones Medical Instrument Co. with the FDA for Oscillaire.

Pre-market Notification Details

• Device ID: K812001
• 510k Number: K812001
• Device Name: OSCILLAIRE
• Classification: Calculator, Pulmonary Function Data
• Applicant: JONES MEDICAL INSTRUMENT CO. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: BZC
• CFR Regulation Number: 868.1880 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1981-07-14
• Decision Date: 1981-08-20

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10863604000312	K812001	000