FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
Medical Monitor (32HS710S)
K Number: K251209
·
Decision Jun 12, 2025
Classifications
1
FEI Numbers
573
Registration Numbers
573
Same Product Code
1391
Applicant Total
23
Review Days
55
Basic Information
- Device Name
- Medical Monitor (32HS710S)
- K Number
- K251209
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- LG Electronics Inc.
- Date Received
- April 18, 2025
- Decision Date
- June 12, 2025
- Product Code
- GCJ
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by LG Electronics Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K243439 | Medical Monitor (27HS714S) | Jan 28, 2025 | Substantially Equivalent |
| K241402 | Medical Monitor (32HR734S) | Aug 12, 2024 | Substantially Equivalent |
| K233599 | X-Clever (ASHK100G) | Mar 18, 2024 | Substantially Equivalent |
| K240130 | Medical Monitor (21HQ613D) | Feb 15, 2024 | Substantially Equivalent |
| K232985 | 24HR513C | Dec 11, 2023 | Substantially Equivalent |
| K232127 | 21HQ513D, 32HL512D, 31HN713D, 32HQ713D | Aug 15, 2023 | Substantially Equivalent |
| K230845 | 32HL512D, 31HN713D, 32HQ713D | Apr 27, 2023 | Substantially Equivalent |
| K223423 | 32HQ713D | Mar 1, 2023 | Substantially Equivalent |
| K223546 | 14HQ721G-B | Jan 27, 2023 | Substantially Equivalent |
| K223789 | 21HQ513D | Jan 9, 2023 | Substantially Equivalent |