Schiller Model SP-100 Spirovit(Tm)
FDA 510(k) K896120 · Schiller America, Inc.
510(k) numberK896120
Submission
- Device name
- Schiller Model SP-100 Spirovit(Tm)
- Applicant
- Schiller America, Inc.
Tustin, CA, US - Received
- October 24, 1989
- Decision date
- January 9, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BZG – Spirometer, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1840
- Specialty
- Anesthesiology
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| K222525 | Alveoair Digital SpirometerBZG · Traditional | Roundworks Technologies Private Limited | 08/28/2023SE |
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| K213872 | ComPAS2BZG · Traditional | Morgan Scientific, Inc. | 07/15/2022SE |
| K212938 | Vitalograph Model 6000 AlphaBZG · Traditional | Vitalograph Ireland, Ltd. | 01/26/2022SE |
More from Vitalograph Ireland, Ltd.
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|---|---|---|
| K973751 | MT-200DQK · Traditional | 08/25/1998SE |
| K973735 | Microvit MT-100DSH · Traditional | 08/25/1998SE |
| K970879 | Cardiovit CS-200LOS · Traditional | 06/25/1997SE |
| K953396 | Cardiovit AT-1C, AT-2CLOS · Traditional | 12/19/1995SE |
| K954066 | Miniscope MS-3DPS · Traditional | 10/27/1995SE |
| K941462 | Cardiovit AT-5CLOS · Traditional | 05/19/1995SE |
| K946205 | Cardiovit AT-1, P-80DPS · Traditional | 03/16/1995SE |
| K914970 | Cardiovit CS-100LOS · Traditional | 11/03/1992SE |
| K896121 | Schiller Model SP-200 Spirovit(Tm)BZG · Traditional | 01/09/1990SE |
Questions and answers
When was Schiller Model SP-100 Spirovit(Tm) cleared by the FDA?
Schiller Model SP-100 Spirovit(Tm) (K896120) received a 510(k) decision of Substantially Equivalent on January 9, 1990, 77 days after the submission was received.
What is the product code of K896120?
The FDA product code is BZG – Spirometer, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 868.1840.