Identity
- Trade Name
- Chairmount, Royal OS1 FDA UDI
- Generic Name
- Inhalational analgesia unit FDA UDI
- Device Name
- Chairmount, Royal OS1 FDA UDI
- Model / Reference
- 31007-6 FDA UDI
- Description
- Chairmount, Royal OS1 FDA UDI
Identifiers
- Catalog Number
- 31007-6 FDA UDI
- Primary DI / UDI-DI
- 00813830027693 FDA UDI
- 510(k) Number
- K970163 FDA UDI
- FDA Product Code
- BSZ FDA UDI
- GMDN Term
- Inhalational analgesia unit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5160 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Chairmount, Royal OS1 by Accutron — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K970163 also covers:
- Chair Conversion Kit — ACCUTRON
- Chairmount, Adec 511 — ACCUTRON
- Chairmount, Boyd Oral Surgery S2600 — ACCUTRON
- Chairmount, MTI Oral Surgery 721 — ACCUTRON
- Chairmount, Sirona Intego — ACCUTRON
- Chairmount, Sirona Teneo — ACCUTRON
- FRU, Oxygen Outlet, Stand-Alone — ACCUTRON
- FRU, Oxygen Selector Valve — ACCUTRON
- Flowmeter, CM Assy — ACCUTRON
- Flowmeter, CM DISS — ACCUTRON
- Kit, PC To Remote Outlet — ACCUTRON
- Loaner, CM, 2 Post, Instant — ACCUTRON
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Accutron
Sources (1)
- FDA UDI efa17f19-ac0d-4b71-96ff-2507981119d3 36 fields · synced Jun 1, 2026