Spirometer, Mini Positive
FDA 510(k) K782145 · Boehringer Laboratories
510(k) numberK782145
Submission
- Device name
- Spirometer, Mini Positive
- Applicant
- Boehringer Laboratories
Mchenry, IL, US - Received
- December 27, 1978
- Decision date
- January 31, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BZK – Spirometer, Monitoring (W/Wo Alarm)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1850
- Specialty
- Anesthesiology
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| K103578 | Philips NM3 Respiratory Monitor with VentassistBZK · Traditional | Respironics Novametrix, LLC | 06/02/2011SE |
| K091853 | Wright Respirometer, Mark 8, and 14 Respirometer, Model 700-021, 700-008, 700-014BZK · Traditional | Nspire Health, Inc. | 09/21/2009SE |
| K092217 | Mercury VCO2BZK · Special | Respironics Novametrix, Inc. | 08/21/2009SE |
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Questions and answers
When was Spirometer, Mini Positive cleared by the FDA?
Spirometer, Mini Positive (K782145) received a 510(k) decision of Substantially Equivalent on January 31, 1979, 35 days after the submission was received.
What is the product code of K782145?
The FDA product code is BZK – Spirometer, Monitoring (W/Wo Alarm), a Class II (moderate risk) device regulated under 21 CFR 868.1850.