FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HM-SPIRO
K Number: K951718
·
Decision Dec 20, 1995
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
227
Applicant Total
10
Review Days
251
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Basic Information
- Device Name
- HM-SPIRO
- K Number
- K951718
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1840
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Hill-Med, Inc.
- Date Received
- April 13, 1995
- Decision Date
- December 20, 1995
- Product Code
- BZG
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| BZG | Spirometer, Diagnostic | FDA class 2 | Anesthesiology |
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Other Clearances by Hill-Med, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K993991 | HM-930 ELECTROSURGICAL UNIT | May 30, 2000 | Substantially Equivalent |
| K981781 | ELECTROSURGICAL UNIT | Dec 4, 1998 | Substantially Equivalent |
| K961473 | HM-88011 SOLID STATE ELECTR SURGICAL UNIT | May 7, 1996 | Substantially Equivalent |
| K940140 | HM-CRYO | Jun 27, 1994 | Substantially Equivalent |
| K932782 | HM-0660 | Mar 23, 1994 | Substantially Equivalent |
| K932896 | HM-0690 COLPOSCOPE | Mar 23, 1994 | Substantially Equivalent |
| K932817 | HM-880 I | Mar 9, 1994 | Substantially Equivalent |
| K932818 | HM-880 | Feb 25, 1994 | Substantially Equivalent |
| K932720 | HM-0970 | Sep 7, 1993 | Substantially Equivalent |