ICE PACK, REUSABLE FLEXIBLE— 510(k) K790009
Substantially EquivalentAckrad Laboratories
FDA 510(k) clearance K790009 for ICE PACK, REUSABLE FLEXIBLE, Substantially Equivalent on 1979-01-22. Applicant: Ackrad Laboratories. Device class: 1.
Clearance details
- Applicant
- Ackrad Laboratories
- Product code
- Code IME
- Device class
- Class 1
- Regulation
- 21 CFR 890.5700
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code IME
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view all- K021272 — SIB CATHETER, MODEL 61-7005
- K020954 — H/S PROCEDURE TRAY (5F), H/S PROCEDURE TRAY (7F), H/S ELLIPTOSPHERE PROCEDURE TRAY & MULTIPURPOSE PROCEDURE TRAY
- K020951 — H/S CATHETER SET (5F), MODEL 61-5005; H/S CATHETER SET (7F), MODEL 61-5007
- K970492 — INTRAUTERINE INSEMINATION AND SONOHYSTEROGRAPHY CATHETER
- K961752 — H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607)
Adverse events under product code IME
product code IME- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.