FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PM 2000 AUTOMATIC PATIENT CHAIR
K Number: K781597
·
Decision Sep 27, 1978
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
16
Applicant Total
2
Review Days
12
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Basic Information
- Device Name
- PM 2000 AUTOMATIC PATIENT CHAIR
- K Number
- K781597
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1800
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Time Motion System Co.
- Date Received
- September 15, 1978
- Decision Date
- September 27, 1978
- Product Code
- FFG
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| FFG | Device, Urine Flow Rate Measuring, Non-Electrical, Disposable | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
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URINARY DRAINAGE CONTAINER 2013 WITH
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Other Clearances by Time Motion System Co.
| K Number | Device Name | ||
|---|---|---|---|
| K820789 | CANCAN 2002 DENTAL PATIENT CHAIR | May 3, 1982 | Substantially Equivalent |