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510(k) K781681

PHIPIOLOGICAL SYNCHRONIZER PART#205 by Brattle Instrument Corp. — Product Code IXQ

K781681 is an FDA 510(k) premarket notification submitted by Brattle Instrument Corp. for the device "PHIPIOLOGICAL SYNCHRONIZER PART#205". The FDA issued a decision of Substantially Equivalent on October 17, 1978. The device falls under product code IXQ (Table, Radiographic, Stationary Top), a Class II device regulated under 21 CFR 892.1980. Brattle Instrument Corp. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 1978
Date Received
October 2, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Radiographic, Stationary Top
Device Class
Class II
Regulation Number
892.1980
Review Panel
RA
Submission Type

Other clearances by Brattle Instrument Corp.

  • K810588 — SYNCHRONIZER #208 (April 10, 1981)
  • K802978 — TRANSCUTANEOUS BLOOD OXYGEN MONITOR #300 (February 2, 1981)
  • K770692 — MONITOR, FETAL, NO. L04-1100 (April 26, 1977)
  • K770296 — FETAL MONITOR, PART #101-11009 (March 9, 1977)
  • K770295 — ABDOMINAL ECG PROCESSOR FOR FETAL MONI. (March 9, 1977)
  • K770297 — FETAL MONITOR, PART #100-11009 (March 9, 1977)

Other clearances for product code IXQ

  • K973842 — CARBON FIBER CONFORMAL COUCH TOP (December 5, 1997)
  • K960083 — MOVABLE CANTILEVERED RADIOGRAPHIC TABLE XRT 100, 200 & 300 (July 24, 1996)
  • K954225 — MED-TEC HAND GRIP (November 14, 1995)
  • K946262 — EURO, SCST, SCCFT ATLAS RADIOLOGIC TABLES (February 15, 1995)
  • K942916 — OCTOPAQUE UNIVERSAL (September 8, 1994)
  • K942190 — ID100 MOBILE FLUOROSCOPIC EXAMINING TABLE (August 17, 1994)
  • K913425 — DIAL-A-RAD PORTA RAD TABLE (November 24, 1992)
  • K923775 — R-MADE HEAD/ARM SUPPORT (October 20, 1992)
  • K920729 — BUCKY TABLE BK-12 (April 27, 1992)
  • K914351 — CLINITRON C-10 (February 14, 1992)

FDA data resources