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Device is a spirometer for lung-function testing. For testing lung-function in all people from children to adults, generally used by a physician or by a respiratory therapist or technician. Device is portable and thus can be used at home, in the factory, in the hospital, in the doctor's office.

Device is a spirometer for lung-function testing. Device is portable.

This document is an FDA 510(k) clearance letter for the MIR Spirobank Spirometer, dated December 21, 1998. It primarily confirms the device's substantial equivalence to predicate devices and allows it to be marketed.

However, this document does NOT contain the detailed information necessary to answer the questions about acceptance criteria, study design, sample sizes, expert qualifications, or ground truth establishment.

The document states:

• Device Name: MIR Spirobank Spirometer (Page 2)
• Intended Use: "Device is a spirometer for lung-function testing. For testing lung-function in all people from children to adults, generally used by a physician or by a respiratory therapist or technician. Device is portable and thus can be used at home, in the factory, in the hospital, in the doctor's office." (Page 2)
• Regulatory Class: II (two) (Page 1)
• Product Code: 73 BZG (Page 1)

Therefore, I cannot provide the requested information based on the provided text. This type of information is typically found in the 510(k) submission itself, often in sections detailing device performance testing or clinical studies, which are not part of this clearance letter.

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