Spirocare 108-B
FDA 510(k) K782016 · Marion Laboratories, Inc.
510(k) numberK782016
Submission
- Device name
- Spirocare 108-B
- Applicant
- Marion Laboratories, Inc.
Mchenry, IL, US - Received
- December 5, 1978
- Decision date
- December 13, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BWF – Spirometer, Therapeutic (Incentive)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5690
- Specialty
- Anesthesiology
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| K874554 | Enviclusive (TM)NAD · Traditional | 03/11/1988SE |
| K874552 | Envisan PadKOZ · Traditional | 01/22/1988SN |
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| K870864 | Culturette Brand CDT Clostridium Difficile TestLLH · Traditional | 04/14/1987SE |
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Questions and answers
When was Spirocare 108-B cleared by the FDA?
Spirocare 108-B (K782016) received a 510(k) decision of Substantially Equivalent on December 13, 1978, 8 days after the submission was received.
What is the product code of K782016?
The FDA product code is BWF – Spirometer, Therapeutic (Incentive), a Class II (moderate risk) device regulated under 21 CFR 868.5690.