Hm-Spiro
FDA 510(k) K951718 · Hill-Med, Inc.
510(k) numberK951718
Submission
- Device name
- Hm-Spiro
- Applicant
- Hill-Med, Inc.
Palm Harbor, FL, US - Received
- April 13, 1995
- Decision date
- December 20, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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| K231416 | Air Next (NVD-02)BZG · Traditional | Nuvoair AB | 01/18/2024SE |
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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.
| 510(k) | Device | Decision |
|---|---|---|
| K993991 | HM-930 Electrosurgical UnitGEI · Traditional | 05/30/2000SE |
| K981781 | Electrosurgical UnitGEI · Traditional | 12/04/1998SE |
| K961473 | HM-88011 Solid State Electr Surgical UnitGEI · Traditional | 05/07/1996SE |
| K940140 | Hm-CryoGEH · Traditional | 06/27/1994SE |
| K932896 | HM-0690 ColposcopeHEX · Traditional | 03/23/1994SE |
| K932782 | HM-0660HEX · Traditional | 03/23/1994SE |
| K932817 | HM-880 IGEI · Traditional | 03/09/1994SE |
| K932818 | HM-880GEI · Traditional | 02/25/1994SE |
| K932720 | HM-0970HRM · Traditional | 09/07/1993SE |
Questions and answers
When was Hm-Spiro cleared by the FDA?
Hm-Spiro (K951718) received a 510(k) decision of Substantially Equivalent on December 20, 1995, 251 days after the submission was received.
What is the product code of K951718?
The FDA product code is BZG – Spirometer, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 868.1840.