FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DHD EMERALD PRODUCT
K Number: K970596
·
Decision May 16, 1997
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
107
Applicant Total
11
Review Days
87
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Basic Information
- Device Name
- DHD EMERALD PRODUCT
- K Number
- K970596
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5690
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Dhd Diemolding Healthcare Div.
- Date Received
- February 18, 1997
- Decision Date
- May 16, 1997
- Product Code
- BWF
- 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 |
|---|---|---|---|
| BWF | Spirometer, Therapeutic (Incentive) | FDA class 2 | Anesthesiology |
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Other Clearances by Dhd Diemolding Healthcare Div.
| K Number | Device Name | ||
|---|---|---|---|
| K973532 | STEALTH, METERED DOSE INHALER (MDI) SPACER WITHOUT INTEGRAL ACTUATOR | Mar 19, 1998 | Substantially Equivalent |
| K961973 | DHD ACE WITH MASK KIT | Aug 15, 1996 | Substantially Equivalent |
| K953206 | DHD METERED DOSE INHALER (MDI) SPACER (MODIFICATION) | Aug 28, 1995 | Substantially Equivalent |
| K945118 | EXPIRATORY BREATHING EXERCISER | Jan 13, 1995 | Substantially Equivalent |
| K944900 | THERAPEP | Jan 6, 1995 | Substantially Equivalent |
| K926301 | ACE AEROSOL ENHANCER, HAND HELD ORAL INHALATION CO | Jul 21, 1993 | Substantially Equivalent |
| K922537 | DURALIFE | Dec 4, 1992 | Substantially Equivalent |
| K913726 | DURALIFE(TM) | Feb 7, 1992 | Substantially Equivalent |
| K913326 | DHD METERED DOSE INHALER (MDI) SPACER | Jan 7, 1992 | Substantially Equivalent |
| K911294 | ULTRASET CATHETER | Jun 10, 1991 | Substantially Equivalent |