FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Skeeper
DI: 08809427311032
·
Model: SM-300
·
Smartsound Corportation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Skeeper
- Primary DI
- 08809427311032
- Version / Model
- SM-300
- Company Name
- Smartsound Corportation
- Labeler DUNS
- 688518952
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-01-12
- Public Version
- 1
- Public Version Date
- 2026-01-20
- Public Version Status
- New
- Public Device Record Key
- 9ac5618b-9658-41ff-b95e-c2ceaecdcb9a
- Distribution End Date
- 2026-01-12
Device Description
Skeeper is an electronic stethoscope that measures, filters and amplifies the sound inside the human body. Users can hear the sound through earphones connected to the device or heart the sound by transmitting it to a smart mobile device. Skeeper mobile application installed on a smart mobile device can display sound data in the form of a frequency graph or analyze the data to display heartrate (BPM), Heart beat regularity(%) etc.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DQD | Stethoscope, Electronic | Cardiovascular | 870.1875 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13754 | Electronic acoustic stethoscope | An external, hand-held, electronic listening device designed to be used by a healthcare professional for real-time detection and amplification of body sounds (e.g., heart, blood vessels, lungs) that may be difficult to perceive when using a mechanical stethoscope; it is not designed for electrocardiography (ECG). It is typically designed to be connected to a computing device, which may operate interpretive software sometimes provided with the stethoscope, for recording and/or displaying the results in the form of a graph [phonocardiogram (PCG)]. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08809427311032 | GS1 |
Customer Contacts
- Phone
- +8225752252
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K230613 | 000 |