FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIGI-SNAP
K Number: K984169
·
Decision May 26, 1999
Classifications
1
FEI Numbers
84
Registration Numbers
84
Same Product Code
160
Applicant Total
6
Review Days
187
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Basic Information
- Device Name
- DIGI-SNAP
- K Number
- K984169
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.2375
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Snap Laboratories, LLC
- Date Received
- November 20, 1998
- Decision Date
- May 26, 1999
- Product Code
- MNR
- 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 |
|---|---|---|---|
| MNR | Ventilatory Effort Recorder | FDA class 2 | Anesthesiology |
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Other Clearances by Snap Laboratories, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K080321 | SNAP MODEL 7 SNORING AND APNEA RECORDING AND ANALYSIS SYSTEM | May 23, 2008 | Substantially Equivalent |
| K002095 | SNAP MODEL 6 | Mar 2, 2001 | Substantially Equivalent |
| K992322 | SNAP MODEL 5 | Feb 2, 2000 | Substantially Equivalent |
| K971184 | OXI-SNAP | Oct 1, 1997 | Substantially Equivalent |
| K944524 | SNAP TESTING DEVICE | Oct 26, 1995 | Substantially Equivalent |