FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
3M LITTMANN ELECTRONIC STETHOSCOPE
K Number: K961848
·
Decision Sep 26, 1997
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
153
Applicant Total
9
Review Days
501
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Basic Information
- Device Name
- 3M LITTMANN ELECTRONIC STETHOSCOPE
- K Number
- K961848
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1875
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Minnesota Mining and Mfg. Co.
- Date Received
- May 13, 1996
- Decision Date
- September 26, 1997
- Product Code
- DQD
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DQD | Stethoscope, Electronic | FDA class 2 | Cardiovascular |
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Other Clearances by Minnesota Mining and Mfg. Co.
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|---|---|---|---|
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| K990482 | 3M CLINPRO PROPHY PASTE, MODEL 12611 | May 13, 1999 | Substantially Equivalent |
| K965043 | 3M 1830 FLUID BLOCK ANTI-FOG TIE-ON SURGICAL MASK AND 3M 1830FS FLUID BLOCK ANTI-FOG TIE-ON SURGICAL MASK WITH FACE SHIE | Mar 10, 1997 | Substantially Equivalent |
| K954900 | 3M RED DOT ECG LEAD WIRES A | Jul 15, 1996 | Substantially Equivalent |
| K940446 | 3M MODEL 3000 & MODEL 3100 INFUSION PUMP (MODIFICATION) | Aug 15, 1994 | Substantially Equivalent - Subject to Tracking Reg. |
| K837117 | 3M FERLIC CHEST FILTER, X-RAY COMPENSATING FILTER | Mar 9, 1983 | Substantially Equivalent |