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Skin Temp Probe - 10 AIP080

by Rpi

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K020219

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00841034103158 UDI-DI Date9 Dec 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK020219 Date12 Apr 2002DecidedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Skin Temp Probe - 10
Generic name
Electrocardiographic lead set, reusable
Model / Ref / Catalog
AIP080
Primary DI / UDI-DI
00841034103158
510(k) Number
FDA product code
DSA
GMDN term
Electrocardiographic lead set, reusable
Device class
Class II
Regulation number
870.2900
GUDID distribution status
In Commercial Distribution

Related devices

Category: Electrocardiographic lead set, reusable

Cleared under the same submission (K020219)

Show all (12)

Other devices from Rpi

See all devices from Rpi →

Properties

  • Lot / batch number

Other properties (14)

  • Supplied sterile: No
  • Sterilise before use: No
  • Single use: No
  • Implantable: No
  • Contains latex: No
  • Prescription use: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Expiration date: No
  • Manufacturing date: No