FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PHIPIOLOGICAL SYNCHRONIZER PART#205
K Number: K781681
·
Decision Oct 17, 1978
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
26
Applicant Total
7
Review Days
15
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Basic Information
- Device Name
- PHIPIOLOGICAL SYNCHRONIZER PART#205
- K Number
- K781681
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1980
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Brattle Instrument Corp.
- Date Received
- October 2, 1978
- Decision Date
- October 17, 1978
- Product Code
- IXQ
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| IXQ | Table, Radiographic, Stationary Top | FDA class 2 | Radiology |
Similar 510(k) Clearances
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Other Clearances by Brattle Instrument Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K810588 | SYNCHRONIZER #208 | Apr 10, 1981 | Substantially Equivalent |
| K802978 | TRANSCUTANEOUS BLOOD OXYGEN MONITOR #300 | Feb 2, 1981 | Substantially Equivalent |
| K770692 | MONITOR, FETAL, NO. L04-1100 | Apr 26, 1977 | Substantially Equivalent |
| K770296 | FETAL MONITOR, PART #101-11009 | Mar 9, 1977 | Substantially Equivalent |
| K770295 | ABDOMINAL ECG PROCESSOR FOR FETAL MONI. | Mar 9, 1977 | Substantially Equivalent |
| K770297 | FETAL MONITOR, PART #100-11009 | Mar 9, 1977 | Substantially Equivalent |