Microdl Diarycard Spirometer
FDA 510(k) K965042 · Micro Direct, Inc.
510(k) numberK965042
Submission
- Device name
- Microdl Diarycard Spirometer
- Applicant
- Micro Direct, Inc.
Auburn, ME, US - Received
- December 17, 1996
- Decision date
- June 17, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BZG – Spirometer, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1840
- Specialty
- Anesthesiology
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| K963035 | Micro SpirometerBZG · Traditional | 11/01/1996SE |
| K950197 | MicrocoCCJ · Traditional | 10/17/1996SE |
| K940375 | Micro MPMCAP · Traditional | 11/21/1994SE |
Questions and answers
When was Microdl Diarycard Spirometer cleared by the FDA?
Microdl Diarycard Spirometer (K965042) received a 510(k) decision of Substantially Equivalent on June 17, 1997, 182 days after the submission was received.
What is the product code of K965042?
The FDA product code is BZG – Spirometer, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 868.1840.